Configurable robotic surgical system with virtual rail and flexible endoscope

ABSTRACT

Systems and methods for moving or manipulating robotic arms are provided. A group of robotic arms are configured to form a virtual rail or line between the end effectors of the robotic arms. The robotic arms are responsive to outside force such as from a user. When a user moves a single one of the robotic arms, the other robotic arms will automatically move to maintain the virtual rail alignments. The virtual rail of the robotic arm end effectors may be translated in one or more of three dimensions. The virtual rail may be rotated about a point on the virtual rail line. The robotic arms can detect the nature of the contact from the user and move accordingly. Holding, shaking, tapping, pushing, pulling, and rotating different parts of the robotic arm elicits different movement responses from different parts of the robotic arm.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.15/681,051, filed Aug. 18, 2017, which is a continuation of U.S.application Ser. No. 14/871,253, filed Sep. 30, 2015, now U.S. Pat. No.9,737,371, which claims the benefit of U.S. Provisional ApplicationsNos. 62/057,936, filed Sep. 30, 2014, 62/096,825, filed Dec. 24, 2014,and 62/211,135, filed Aug. 28, 2015, all of which are incorporatedherein by reference. Any and all applications for which a foreign ordomestic priority claim is identified in the Application Data Sheet asfiled with the present application are hereby incorporated by referenceunder 37 CFR 1.57.

The subject matter of this application is related to the subject matterof the following patent applications: provisional application Ser. No.62/096,825; provisional application Ser. No. 62/057,936; provisionalapplication Ser. No. 61/940,180; application Ser. No. 14/523,760;application Ser. No. 14/542,373; application Ser. No. 14/542,387;application Ser. No. 14/542,403; and application Ser. No. 14/542,429,which are incorporated herein by reference.

FIELD OF THE INVENTION

The field of the present application pertains to medical devices. Moreparticularly, the field of the invention pertains to a mechanical tooland manufacturing techniques for catheters and endoscopes for roboticassisted surgery as well as systems and tools for robotic-assistedendolumenal or other surgery.

BACKGROUND

Endoscopy is a widely-used, minimally invasive technique for bothimaging and delivering therapeutics to anatomical locations within thehuman body. Typically a flexible endoscope is used to deliver tools toan operative site inside the body—e.g., through small incisions or anatural orifice in the body (nasal, anal, vaginal, urinary, throat,etc.)—where a procedure is performed. Endoscopes may have imaging,lighting and steering capabilities at the distal end of a flexible shaftenabling navigation of non-linear lumens or pathways.

Endolumenal surgical applications involve positioning and driving anendoscope to a desired anatomical position. To assist with endolumenalnavigation, the endoscopes often have a means to articulate a smalldistal bending section. Today's endoscopic devices are typically handheld devices with numerous levers, dials, and buttons for variousfunctionalities, but offer limited performance in terms of articulation.For control, physicians control the position and progress of theendoscope by manipulating the levers or dials in concert with twistingthe shaft of the scope. These techniques require the physician tocontort their hands and arms when using the device to deliver the scopeto the desired position. The resulting arm motions and positions areawkward for physicians; maintaining those positions can also bephysically taxing. Thus, manual actuation of bending sections is oftenconstrained by low actuation force and poor ergonomics.

Today's endoscopes also require support personnel to both deliver,operate and remove operative, diagnostic or therapeutic devices from thescope while the physician maintains the desired position. Today'sendoscopes also utilize pull wires that create issues with curvealignment and muscling. Some procedures require fluoroscopy or segmentedCT scans to assist in navigating to the desired location, particularlyfor small lumen navigation.

Therefore, it would be beneficial to have a system and tools forendolumenal robotic procedures that provide improved ergonomics,usability, and navigation. Application of these technologies may also beapplied to other surgical procedures, such as vascular surgeries. Itwould also be beneficial to have an improved control for catheters andendoscopes to have a controlled bend with a neutral axis remainingconstant during bending operations. Additionally it would be beneficialto have an improved method for manufacturing such catheters andendoscopes, i.e., endoscopes and catheters that maintain a neutral axisdespite the bending, stretching, and articulating that occurs during usein anatomical structures and spaces.

SUMMARY

An embodiment of the present invention provides a sheath with a lumentherethrough, having a controllable and articulable distal end, which ismounted to a first robotic arm having at least 3 DOF, but preferably 6or more DOF. This embodiment also includes a flexible endoscope having acontrollable and articulable distal end, a light source and videocapture unit at the distal end thereof, and at least one working channelextending therethrough. The flexible endoscope is slidingly disposed inthe lumen of the sheath, and is mounted to a second robotic arm havingat least 3 DOF, but preferably 6 or more DOF. Further included are firstand second modules, operatively coupled, respectfully, to the proximalends of the sheath and flexible endoscope. The modules are mounted tothe first and second robotic arms, thereby mounting the sheath andflexible endoscope to first and second robotic arms, respectively. Themodules provide the mechanics to steer and operate the sheath andflexible endoscope, and receive power and other utilities from therobotic arms. The robotic arms are positioned such that the first moduleis distal to the second module and the proximal end of the sheath isdistal to the proximal end of the flexible endoscope. Movement of thefirst and second robotic arms relative to each other and relative to thepatient causes movement of the sheath relative to the flexible endoscopeand movement of either relative to the patient.

In one embodiment the robots are positioned relative to each other suchthat the sheath and flexible endoscope are in a substantially straight(e.g., approximately 180 degree angle), co-axially aligned configurationbetween the first and second robotic arms, forming a “virtual rail”between the robotic arms. It is to be noted that the virtual rail maytake on angles ranging from 90-180 degrees. Movement of the robotic armsrelative to each other provide axial motion of the sheath and flexibleendoscope relative to each other and the patient, while maintaining thevirtual rail between the robotic arms.

The first and second robotic arms may be on separate mobile carts or onthe same mobile cart. The mobile carts permit transporting the armsbetween procedure rooms or moving within a procedure room to betteraccommodate necessary equipment and the patient bead. Alternatively,though less preferred, the robotic arms could be fixed to the floor orbed.

The present invention alternatively provides multiple modules fordifferent procedures, where the robotic arms retrieve a desired modulefrom a storage place, e.g., a module exchange table or stand, located inthe procedure room. Each module or module pair is designed for aspecific type of procedure.

The modules with the sheath and flexible endoscope combination cannavigate narrow lumens within the human body (e.g., bronchial and otherlung airways, blood vessels, urinary tract inter alia). Additionalmodules may include laproscopic (single or dual port), microsurgicalmodules (which may also have a sheath and flexible endoscopearrangement, but sized appropriately for the eye or other microsurgicalsite). Alternatively the microsurgical modules may be configured to holdrigid instruments sized appropriately for the scale of the surgery.

In embodiments in accordance with the present invention the sheath andflexible endoscope comprising a shaft having a proximal end, a distalend and a controllable bending section, where preferably thecontrollable bending section is a distal bending section. At least onetendon-conduit, preferably four extend through a wall of the shaft wallfrom the proximal end to a distal portion of the controllable bendingsection, preferably the distal end. Preferably, the shaft has anapproximate circular or elliptical cross section. At least one tendon,preferably four extend through each of the at least one tendon-conduits.The tendon-conduits extend through the shaft wall approximately parallelto a central axis of the shaft from the proximal end up to a helixsection of the shaft, and where the tendon-conduits extend through theshaft wall in a helixed or spiral pattern relative to the central axisup to a proximal portion of the controllable bending sections, and wherethe tendon-conduits extend through the shaft wall approximately parallelto the central axis up to a distal portion of the controllable bendingsection. Preferably, the controllable bending section is at the distalend of the shaft. The at least on tendon is secured to the distalportion of the controllable bending section, such that tensioning the atleast one tendon causes the controllable bending section to articulate.

Systems, devices, and methods for robotically assisted endoscopicsurgery are disclosed. An exemplary robotic surgery system may comprisefirst and second robotic arms and a controller for operating the roboticarms. The first and second robotic arms may comprise first and seconddevice manipulators, respectively, that can be coupled to endoscopictool(s). The first and second device manipulators may be configured toalign to form a virtual rail to operate the endoscopic tool(s). Thefirst and/or second robotic arms may be movable in a way to preserve thevirtual rail alignment, thereby maintaining the proper and/or desiredalignment of the endoscopic tool(s). The controller may be configured tomove the first and second device manipulators in a way to maintain thevirtual rail alignment. One or more of the first or second robotic armsmay be responsive to forces exerted on it by the user and forces exertedon one of the robotic arms may cause both arms to move in coordinationwith one another so that the virtual rail alignment is maintained. Thevirtual rail formed by the first and second robotic arms or devicemanipulators may be translated in one or more of the X-axis, Y-axis, orZ-axis (i.e., horizontally and/or vertically). The virtual rail may alsobe pivoted about any point along the virtual line formed by the firstand second robotic arms or device manipulators such as at the center ofone of the device manipulators, a point between the first and seconddevice manipulators, or a point beyond the line segment formed by thefirst and second device manipulators. In some embodiments, the systemmay further comprise a third robotic arm which may be operated by thecontroller and may be configured to form the virtual rail with the firstand second robotic arms. The system may further comprise additionalrobotic arms operable by the controller and configured to form thevirtual rail.

Systems, devices, and methods for user manipulation of robotic surgerysystems are also disclosed. A robotic arm may be responsive to a varietyof different inputs from the forces exerted on it from a user. The usermay exert a force on the robotic arm, such as a tap, a push, a pull, adouble tap or plurality of taps, a hold, or a shake, to name a few. Therobotic force may detect the force exerted and determine the intent ofthe user based on the characteristics of the detected force. Suchcharacteristics may include the location, magnitude, direction, andtiming of the exerted force. Based on the determined user intent, therobotic arm may move in a predetermined pattern.

Aspects of the present disclosure provide methods of moving a system ofrobotic arms. A system of robotic arms may be provided. The system maycomprise a first robotic arm and a second robotic arm. The first andsecond robotic arms may be at a predetermined distance and orientationrelative to one another. The first robotic arm may detect a forceexerted thereon. The first robotic arm may automatically move inresponse to the detected force. The first robotic arm may move with afirst movement vector. The second robotic arm may automatically move inresponse to the detected force such that the predetermined distance andorientation between the first and second robotic arms is maintained. Thesecond robotic arm may move with a second movement vector.

The predetermined distance and orientation between the first and secondrobotic arms may comprise a linear alignment between the first andsecond robotic arms such as a linear alignment between interface ends ofthe first and second robotic arms. In automatically moving the firstrobotic arm, the interface end of the first robotic arm may be pivotedabout a point on a line formed by the first and second robotic arms. Inautomatically moving the second robotic arm, the interface end of thesecond robotic arm may be pivoted about the point on the line formed bythe first and second robotic arms. The point on the line may be betweenthe interface ends of the first and second robotic arms or beyond theinterface ends of the first and second robotic arms.

In automatically moving the second robotic arm in response to thedetected force such that the predetermined distance and orientationbetween the first and second robotic arms is maintained, the first andsecond robotic arms may be translated in unison along one or more of anX-axis, a Y-axis, or a Z-axis. In some embodiments, the first movementvector and the second movement vector are the same. In otherembodiments, the first movement vector and the second movement vectorare different.

The system of robotic arms may further comprise a third robotic arm. Thefirst, second, and third robotic arms which may be at the predetermineddistance and orientation relative to one another. The third robotic armmay automatically move in response to the detected force such that thepredetermined distance and orientation between the first, second, andthird robotic arms is maintained. The third robotic arm may move with athird movement vector. The predetermined distance and orientationbetween the first, second, and third robotic arms may comprise a linearalignment between the first, second, and third robotic arms such as alinear alignment between interface ends of the first, second, and thirdrobotic arms.

In automatically moving the first robotic arm, the interface end of thefirst robotic arm may be pivoted about a point on a line formed by thefirst, second, and third robotic arms. In automatically moving thesecond robotic arm, the interface end of the second robotic arm may bepivoted about the point on the line formed by the first, second, andthird robotic arms. In automatically moving the third robotic arm, theinterface end of the third robotic arm may be pivoted about the point onthe line formed by the first, second, and third robotic arms. The pointon the line may be between two or more of the interface ends of thefirst, second, or third robotic arms or beyond two or more of theinterface ends of the first, second, or third robotic arms. Inautomatically moving the third robotic arm in response to the detectedforce such that the predetermined distance and orientation between thefirst, second, and third robotic arms is maintained, the first, second,and third robotic arms may be translated in unison along one or more ofan X-axis, a Y-axis, or a Z-axis. In some embodiments, two or more ofthe first movement vector, the second movement vector, and the thirdmovement vector are the same. In other embodiments, two or more of thefirst movement vector, the second movement vector, and third movementvector are different.

In some embodiments, the first robotic arm may detect the force exertedon the first robotic arm comprises by detecting a torque exerted on ajoint of the first robotic arm. The force exerted on the first roboticarm may be detected during an operation on a patient.

In some embodiments, a movement mode of the system of robotic arms maybe enabled in response to the detected force. The movement mode of thesystem of robotic arms may comprise one or more of an admittance mode oran impedance mode. The movement mode of the system may be disabled afterthe first and second robotic arms have moved.

Aspects of the present disclosure provide systems of robotic arms. Anexemplary system may comprise a first robotic arm, a second robotic arm,and a controller. The first robotic arm may comprise a force sensorconfigured to detect a force exerted on the first robotic arm. The firstand second robotic arms may be at a predetermined distance andorientation relative to one another. The controller may be coupled tothe first and second robotic arms. The controller may be configured to(i) automatically move the first robotic arm with a first movementvector in response to the detected force and (ii) automatically move thesecond robotic arm with a second movement vector in response to thedetected force such that the predetermined distance and orientationbetween the first and second robotic arms is maintained.

The predetermined distance and orientation between the first and secondrobotic arms may comprise a linear alignment between the first andsecond robotic arms, such as a linear alignment between interface endsof the first and second robotic arms. The controller may be configuredto pivot the interface ends of the first and second robotic arms about apoint on a line formed by the first and second robotic arms. The pointon the line may be between the interface ends of the first and secondrobotic arms or beyond the interface ends of the first and secondrobotic arms.

The controller may be configured to translate the first and secondrobotic arms in unison along one or more of an X-axis, a Y-axis, or aZ-axis. In some embodiments, the first movement vector and the secondmovement vector are the same. In other embodiments, the first movementvector and the second movement vector are different.

The system may further comprise a third robotic arm. The first, second,and third robotic arms may be at the predetermined distance andorientation relative to one another. The controller may be configured toautomatically move the third robotic arm with a third movement vector inresponse to the detected force such that the predetermined distance andorientation between the first, second, and third robotic arms ismaintained. The predetermined distance and orientation between thefirst, second, and third robotic arms may comprise a linear alignmentbetween the first, second, and third robotic arms such as a linearalignment between interface ends of the first, second, and third roboticarms.

The controller may be configured to pivot the interface ends of thefirst, second, and third robotic arms about a point on a line formed bythe first, second, and third robotic arms. The point on the line may bebetween two or more of the interface ends of the first, second, or thirdrobotic arms or beyond two or more of the interface ends of the first,second, or third robotic arms. The controller may be configured totranslate the first, second, and third robotic arms in unison along oneor more of an X-axis, a Y-axis, or a Z-axis. In some embodiments, two ormore of the first movement vector, the second movement vector, and thethird movement vector are the same. In other embodiments, two or more ofthe first movement vector, the second movement vector, and thirdmovement vector are different.

The first robotic arm may comprise at least one joint and at least onelink. The force sensor of the first robotic arm may comprise a torquesensor coupled to the at least one joint. The first robotic arm maycomprise at least one joint and at least one link. The force sensor ofthe first robotic arm may comprise a tactile sensor coupled to the atleast one link.

The controller may be configured to enable a movement mode of the systemof robotic arms in response to the detected force. The movement mode ofthe system of robotic arms may comprise one or more of an admittancemode or an impedance mode. The controller may be configured to disablethe movement mode of the system after the first and second robotic armshave moved.

Aspects of the present disclosure provide methods of moving a roboticarm.

A force exerted on the robotic arm may be detected. The exerted forcemay comprise a force vector and a timing characteristic. A user intentmay be determined based on the force vector and timing characteristic ofthe detected force. The robotic arm may be automatically moved inresponse to the determined user intent. Detecting the force exerted onthe robotic arm may include detecting whether the force is exerted on ajoint, a link, or an interface end of the robotic arm or one or more ofdetecting the force with a torque sensor coupled to a joint of therobotic arm or detecting the force with a tactile sensor coupled to alink of the robotic arm. Determining the user intent may comprisedetermining whether the exerted force is one or more of a hold, a push,a pull, a tap, a plurality of taps, a rotation, or a shake of at least aportion of the robotic arm.

A movement mode of the robotic arm may be enabled before automaticallymoving the robotic arm. The movement mode of the robotic arm may bedisabled after automatically moving the robotic arm. To enable themovement mode, an instruction may be received from a foot pedal incommunication with the robotic arm, a joystick in communication with therobotic arm, a voice command, a detected light, or a computing device incommunication with the robotic arm, to name a few examples. The movementmode may comprise one or more of an impedance mode or an admittancemode.

To determine the user intent, the gesture type of the user may bedetected. Determining the user intent may include determining that theforce exerted on the robotic arm comprises at least one tap on a jointof the robotic arm, and the joint of the robotic arm may beautomatically moved while maintaining a position of at least one otherjoint or interface end of the arm in response to the at least one tap.Determining the user intent may include determining that the forceexerted on the robotic arm comprises a pull on an interface end of therobotic arm while a position of a joint of the robotic arm ismaintained, and the interface end of the robotic arm may be rotated.Determining the user intent may include determining that the forceexerted on the robotic arm comprises a push or pull on an interface endof the robotic arm, and the interface end of the robotic arm may beautomatically moved in response to the push or pull on the interface endand the whole robotic arm may be automatically moved to follow themovement of the interface end.

In some embodiments, an initial position of the robotic arm may bememorized before moving the robotic arm. The robotic arm may be movedback to the initial position after moving the robotic arm in response tothe determined user intent.

Aspects of the present disclosure may provide robotic arm systems. Anexemplary robotic arm system may comprise a robotic arm and acontroller. The robotic arm may comprise a force sensor configured todetect a force exerted on the robotic arm. The exerted force maycomprise a force vector and a timing characteristic. The controller maybe coupled to the robotic arm. The controller may be configured to (i)determine a user intent based on the force vector and timingcharacteristic of the detected force and (ii) automatically move therobotic arm in response to the determined user intent.

The force sensor may be configured to detect whether the force isexerted on a joint, a link, or an interface end of the robotic arm. Theforce sensor may comprise one or more of a torque sensor coupled to ajoint of the robotic arm or a tactile sensor coupled to a link of therobotic arm.

The controller may be configured to determine the user intent bydetermining whether the exerted force is one or more of a hold, a push,a pull, a tap, a plurality of taps, a rotation, or a shake of at least aportion of the robotic arm. The controller may be configured to enable amovement mode of the robotic arm before automatically moving the roboticarm. The controller may be configured to disable the movement mode ofthe robotic arm after automatically moving the robotic arm.

The system may further comprise an external control unit incommunication with the controller to enable the movement mode. Theexternal control unit may comprise one or more of a foot pedal, ajoystick, a microphone, a light detector, or a computing device. Themovement mode may comprise one or more of an impedance mode or anadmittance mode.

The robotic arm may comprise a joint, a link, and an interface end.

The controller may be configured to determine the user intent in manyways through gesture sensing for example. The controller may beconfigured to determine the user intent by determining that the forceexerted on the robotic arm comprises at least one tap on the joint andautomatically move the robotic arm by automatically moving the joint ofthe robotic arm while maintaining a position of at least one other jointor the interface end of the arm in response to the at least one tap. Thecontroller may be configured to determine the user intent by determiningthat the force exerted on the robotic arm comprises a pull on theinterface end of the robotic arm while a position of the joint of therobotic arm is maintained and automatically move the robotic arm byrotating the interface end of the robotic arm. The controller may beconfigured to determine the user intent by determining that the forceexerted on the robotic arm comprises a push or pull on the interface endof the robotic arm and automatically move the robotic arm byautomatically moving the interface end of the robotic arm in response tothe push or pull on the interface end and by automatically moving thewhole robotic arm to follow the movement of the interface end.

The controller may be configured to memorize an initial position of therobotic arm before moving the robotic arm. The controller may beconfigured to move the robotic arm back to the initial position aftermoving the robotic arm in response to the determined user intent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a robotic endoscopic system, in accordance with manyembodiments.

FIG. 2A illustrates a robotic surgery system, in accordance with manyembodiments.

FIG. 2B illustrates an overhead view of the system of FIG. 2A, where ananesthesia cart is provided towards the head of the patient, inaccordance with many embodiments.

FIG. 2C shows a view of the system of FIG. 2A.

FIGS. 2D and 2E illustrate alternative arrangements of the arms 202 and204 of the system of FIG. 2A, showing the versatility of the roboticsurgical system of FIG. 2A, in accordance with many embodiments.

FIG. 3A illustrates an overhead view of a system with multiple virtualrails, in accordance with many embodiments.

FIG. 3B illustrates the use of the robotic surgery system FIG. 3A withan additional robotic arm, associated tool base, and tool, in accordancewith many embodiments.

FIGS. 4A and 4B illustrate the modularity of embodiments of the presentinvention.

FIG. 5A illustrates an implementation of a mechanism changer interfacecoupled to a mechanical arm in a robotic system, in accordance with anembodiment of the present invention.

FIG. 5B illustrates an alternative view of male mechanism changerinterface 502 from FIG. 5A.

FIG. 5C illustrates a reciprocal female mechanism changer interfacecoupled to an instrument device manipulator for connecting with malemechanism changer interface 502 from FIGS. 5A and 5B.

FIG. 5D illustrates an alternative view of a female mechanism changerinterface 508 from FIG. 5C.

FIGS. 6, 7, 8A, and 8B illustrate alternative embodiments of modules fora robotic surgical system of the present invention.

FIG. 9 is an illustration of a robotic catheter that may be used inconjunction with robotic system 100 from FIG. 1 , in accordance with anembodiment of the present invention.

FIGS. 10A, 10B, and 10C illustrate the structure of a sheath of aflexible endoscopic device, in accordance with an embodiment of thepresent invention.

FIGS. 11A and 11B illustrate the structure of a flexible endoscopicdevice in accordance with an embodiment of the present invention.

FIGS. 12A, 12B, 12C, 12D, 12E, 12F, 12G, 12H, 12I, 12J, and 12Killustrate muscling and curve alignment phenomena that manifest inprevious flexible instruments and the improvement shown by an embodimentof the present invention.

FIG. 13 illustrates the structure of flexible endoscopic device with anaxially stiff tube within a lumen, in accordance with an embodiment ofthe present invention.

FIG. 14 illustrates the structure of a helical pattern within a lumen ofa flexible endoscopic device, in accordance with an embodiment of thepresent invention.

FIG. 15A illustrates a robotic catheter from a robotic catheter system,in accordance with an embodiment of the present invention.

FIG. 15B illustrates an alternative view of robotic catheter 1500 fromFIG. 15A.

FIG. 16 illustrates the distal end of a robotic catheter, in accordancewith an embodiment of the present invention.

FIGS. 17A and 17B illustrate independent drive mechanisms of the presentinvention.

FIG. 18 illustrates an alternative view of the independent drivemechanism from FIGS. 17A and 17B illustrate the structure of a sheath ofa flexible endoscopic device, with a tension sensing apparatus inaccordance with an embodiment of the present invention.

FIG. 19A illustrates a cutaway view of the independent drive mechanismfrom FIGS. 17A, 17B, and 18 from an alternate angle.

FIG. 19B illustrates a cutaway view of the previously discussedindependent drive mechanism in combination with a robotic catheter, inaccordance with an embodiment of the present invention.

FIG. 20 illustrates an alternative view of the previously-discussedindependent drive mechanism with pull wires from a robotic catheter inaccordance with an embodiment of the present invention.

FIG. 21 illustrates a conceptual diagram that shows how horizontalforces may be measured by a strain gauge oriented perpendicular to theforces, in accordance with an embodiment of the invention.

FIG. 22 illustrates a flowchart for a method of constructing a catheterdevice with helical lumens, in accordance with an embodiment of thepresent invention.

FIG. 23 illustrates a specialized nose cone for manufacturing flexibleendoscopic devices, in accordance with an embodiment of the presentinvention.

FIG. 24 illustrates a system for manufacturing a flexible endoscopicdevice, in accordance with an embodiment of the present invention.

FIG. 25 illustrates a cross-sectional view of a flexible endoscopicdevice where the pull lumens are arranged symmetrically around thecircumference of the device, in accordance with an embodiment of thepresent invention.

FIG. 26A illustrates a cross-sectional view of a flexible endoscopicdevice where the pull lumens are not arranged symmetrically around thecircumference of the device, in accordance with an embodiment of thepresent invention.

FIG. 26B illustrates an isometric view of the flexible endoscopic devicein FIG. 26A, in accordance with an embodiment of the present invention.

FIG. 27 illustrates a flow diagram for a method for manufacturing theflexible endoscopic device in FIGS. 26A and 26B, in accordance with anembodiment of the present invention.

FIGS. 28A and 28B illustrate the relationship between centerlinecoordinates, diameter measurements and anatomical spaces.

FIG. 29 illustrates a computer-generated three-dimensional modelrepresenting an anatomical space, in accordance with an embodiment ofthe invention.

FIG. 30 illustrates a robotic catheter system that makes use of anelectromagnetic tracker in combination with an electromagnetic fieldgenerator, in accordance with an embodiment in the present invention.

FIG. 31 illustrates a flow diagram for the steps for registration, inaccordance with an embodiment of the present invention.

FIG. 32A illustrates the distal end of a robotic catheter within ananatomical lumen, in accordance with an embodiment of the presentinvention.

FIG. 32B illustrates the robotic catheter from FIG. 32A in use at anoperative site within an anatomical lumen, in accordance with anembodiment of the present invention.

FIG. 32C illustrates the robotic catheter from FIG. 32B in use at anoperative site within an anatomical lumen, in accordance with anembodiment of the present invention.

FIG. 33A illustrates a robotic catheter coupled to a distal flexuresection within an anatomical lumen, in accordance with an embodiment ofthe present invention.

FIG. 33B illustrates a robotic catheter from FIG. 33A with a forcepstool in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention.

FIG. 33C illustrates a robotic catheter from FIG. 33A with a laserdevice in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention.

FIG. 34 illustrates a command console for a robotic surgical system, inaccordance with an embodiment of the present invention.

FIGS. 35A and 35B illustrate different views of a robotic cathetersystem, in accordance with an embodiment of the present invention.

FIG. 36 illustrates an isometric view of a robotic catheter system wherethe angle of the virtual rail is greatly increased, in accordance withan embodiment of the present invention.

FIGS. 37A, 37B, 37C, and 37D illustrate a series of top views of avascular procedure where the use of mechanical arms reduces catheterbuckling and wasted length, in accordance with an embodiment of thepresent invention.

FIGS. 38A and 38B illustrate a vascular procedure where a roboticcatheter may be inserted into the carotid artery, in accordance with anembodiment of the present invention.

FIG. 39 illustrates a vascular procedure where a robotic catheter may beinserted into the brachial artery, in accordance with an embodiment ofthe present invention.

FIGS. 40A and 40B illustrate a vascular procedure where a roboticcatheter may be inserted into the radial artery, in accordance with anembodiment of the present invention.

FIG. 41 shows a flow chart illustrating a method for aligning the armsof a robotic surgery system, in accordance with many embodiments;

FIG. 42A shows a schematic of the aligned arms of a robotic surgerysystem translating in up to three dimensions, in accordance with manyembodiments;

FIG. 42B shows a schematic of the aligned arms of a robotic surgerysystem pivoting about one of the device manipulators of robotic arms, inaccordance with many embodiments.

FIG. 42C shows a schematic of the aligned arms of a robotic surgerysystem pivoting about a point between two of the device manipulators ofrobotic arms, in accordance with many embodiments.

FIG. 42D shows a schematic of the aligned arms of a robotic surgerysystem pivoting about a point beyond two of the device manipulators ofrobotic arms, in accordance with many embodiments.

FIG. 43 shows a flow chart illustrating a method for manipulating therobotic arm(s) of a robotic surgery system, in accordance with manyembodiments.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses, and tomodifications and equivalents thereof. Thus, the scope of the claimsappended hereto is not limited by any of the particular embodimentsdescribed below. For example, in any method or process disclosed herein,the acts or operations of the method or process may be performed in anysuitable sequence and are not necessarily limited to any particulardisclosed sequence. Various operations may be described as multiplediscrete operations in turn, in a manner that may be helpful inunderstanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

Overview.

An endolumenal surgical robotic system provides the surgeon with theability to sit down in an ergonomic position and control a roboticendoscopic tool to the desired anatomical location within a patientwithout the need for awkward arm motions and positions.

The robotic endoscopic tool has the ability to navigate lumens withinthe human body with ease by providing multiple degrees of freedom atleast two points along its length. The tool's control points provide thesurgeon with significantly more instinctive control of the device as itnavigates a tortuous path within the human body. The tip of the tool isalso capable of articulation from zero to ninety degrees for all threehundred and sixty degrees of roll angles.

The surgical robotic system may incorporate both external sensor-basedand internal vision-based navigation technologies in order to assist thephysician with guidance to the desired anatomical location within thepatient. The navigational information may be conveyed in eithertwo-dimensional display means or three-dimensional display means.

System Components.

FIG. 1 is a robotic endoscopic system, in accordance with an embodimentof the present invention. As shown in FIG. 1 , robotic system 100 maycomprises a system cart 101 with at least one mechanical arm, such asarm 102. The system cart 101 may be in communication with aremotely-located command console (not shown). In practice, the systemcart 101 may be arranged to provide access to a patient, while aphysician may control the system 100 from the comfort of the commandconsole. In some embodiments, the system 100 may be integrated into theoperating table or bed for stability and access to the patient.

Within system 100, arm 102 may be fixedly coupled to a system cart 101that contains a variety of support systems, including controlelectronics, power sources and optical sources in some embodiments. Thearm 102 may be formed from a plurality of linkages 110 and joints 111 toenable access to the patient's operative region. The system cart 101 maycontain source of power 112, pneumatic pressure 113, and control andsensor electronics 114—including components such as central processingunit, data bus, control circuitry, and memory—and related actuators ormotors that may drive arms such as arm 102. Power may be conveyed fromthe system cart 101 to the arm 102 using a variety of means known to oneskilled in the art such as electrical wiring, gear heads, air chambers.The electronics 114 in system cart 101 may also process and transmitcontrol signals communicated from a command console.

The system cart 101 may also be mobile, as shown by the wheels 115. Insome embodiments, the system cart may capable of being wheeled to thedesired location near the patient. System cart(s) 101 may be located invarious locations in the operating room in order to accommodate spaceneeds and facilitate appropriate placement and motion of modules andinstruments with respect to a patient. This capability enables the armsto be positioned in locations where they do not interfere with thepatient, doctor, anesthesiologist or any supportive surgical equipmentrequired for the selected procedure. During procedures, the arms withinstruments will work collaboratively via user control through separatecontrol devices, which may include a command console with hapticdevices, joystick, or customized pendants.

Mechanical Arms.

The proximal end of arm 102 may be fixedly mounted or coupled to thecart 101. Mechanical arm 102 comprises a plurality of linkages 110,connected by at least one joint per arm, such as joints 111. Ifmechanical arm 102 is robotic, joints 111 may comprise one or moreactuators in order to affect movement in at least one degree of freedom.The arm 102, as a whole, preferably has more than three degrees offreedom. Through a combination of wires and circuits, each arm may alsoconvey both power and control signals from system cart 101 to theinstruments located at the end of their extremities.

In some embodiments, the arms may be fixedly coupled to the operatingtable with the patient. In some embodiments, the arms may be coupled tothe base of the operating table and reach around to access patient.

In some embodiments, the mechanical arms may not be robotic ally-driven.In those embodiments, the mechanical arms are comprised of linkages andset up joints that use a combination of brakes and counter-balances tohold the position of the arms in place. In some embodiments,counter-balances may be constructed from gas springs or coil springs.Brakes, such as fail safe brakes, may be mechanical orelectro-mechanical. In some embodiments, the arms may begravity-assisted passive support arms.

Distally, each arm may be coupled to an Instrument Device Manipulator(IDM), such as 117, through a Mechanism Changer Interface (MCI), such as116. In the preferred embodiment, the MCI 116 may contain connectors topass pneumatic pressure, electrical power, electrical signals, andoptical signals from the arm to the IDM 117. In some embodiments, MCI116 may be as simple as a set screw or base plate connection.

IDM 117 may have a variety of means for manipulating a surgicalinstrument including, direct drive, harmonic drive, geared drives, beltsand pulleys, or magnetic drives. One skilled in the art would appreciatethat a variety of methods may be used control actuators on instrumentdevices.

In some embodiments, the IDM may be removable. Within the roboticsystem, the MCIs, such as 116, may be interchangeable with a variety ofprocedure-specific IDMs, such as 117. In this embodiment, theinterchangeability of the IDMs allows robotic system 100 to performdifferent procedures.

Preferred embodiments may use a robotic arm with joint level torquesensing having a wrist at the distal end, such as Kuka AG's LBR5. Theseembodiments have a robotic arm with seven joints, with redundant jointsprovided to avoid potential arm collision with a patient, other robotarms, operating table, medical personal or equipment proximate to theoperative field, while maintaining the wrist at the same pose so as notto interrupt an ongoing procedure. The skilled artisan will appreciatethat a robotic arm with at least three degrees of freedom, and morepreferably six or more degrees of freedom, will fall within theinventive concepts described herein, and further appreciate that morethan one arm may be provided with additional modules, where each arm maybe commonly or separately mounted on either a cart, multiple carts, or asurgical bed or table.

Virtual Rail Configuration.

Arm 102 in system 100 may be arranged in a variety of postures for usein a variety of procedures. For example, in combination with anotherrobotic system with at least one robotic arm, the arm 102 of system 100may be arranged to align distally-mounted IDMs to form a “virtual rail”that facilitates the insertion and manipulation of an endoscopic tool118. For other procedures, the arms may be arranged differently. Thus,the use of arms in system 100 provides flexibility not found in roboticsystems whose design is directly tied to specific medical procedure. Thearms of system 100 provide potentially much greater stroke and stowage.In other embodiments, where multiple arms are coupled to surgicalbed/table platform, a multiplicity of virtual rail arrangements may beconfigured for a variety of different procedures.

FIG. 2A illustrates a robotic surgery system 200 in accordance with anembodiment of the present invention. System 200 comprises two systemcarts that collectively comprise first arm 202 and second arm 204holding endoscopic tool bases 206 and 208, respectively. Tool base 206has controllable endoscope sheath 210 operatively connected thereto.Tool base 208 has flexible endoscope leader 212 operatively connectedthereto. In some embodiments, the tool bases may be coupled to arms 202and 204 through IDMs and/or MCIs as disclosed earlier.

Arms 202 and 204 align tool bases 206 and 208 such that proximal end 216of sheath 210 is distal of the proximal end 222 of leader 212, and suchthat leader 212 remains axially aligned with sheath 210 at anapproximate angle of 180 degrees between the two arms, resulting in a“virtual rail” where the rail comprising of sheath 210 and leader 212 isapproximately straight, or at 180 degrees. As will be described later,the virtual rail may have angles between 90-180 degrees. In oneembodiment, sheath 210, with leader 212 slidingly disposed therethrough,is robotically inserted through, for example, a tracheal tube (notshown) in the mouth of and into patient 211, and ultimately into thepatient's bronchial system, while continually maintaining the virtualrail during insertion and navigation. The arms may move sheath 210 andendoscope 212 axially relative to each other and in to or out of patient211 under the control of a doctor (not shown) at a control console 203(from FIG. 2B). In another embodiment, the sheath 210, with leader 212slidingly disposed therethrough, may be robotically inserted through apatient's urethra and ultimately into the patient's urinary tract.

Navigation is achieved, for example, by advancing sheath 210 along withleader 212 into the patient 211, then leader 212 may be advanced beyonddistal end 213 of the sheath, and the sheath 210 may then be broughteven with the leader 212, until a desired destination is reached. Othermodes of navigation may be used, such as and not by way of limitationusing a guidewire through the working channel of the leader 212. Thephysician may be using any number of visual guidance modalities orcombination thereof to aid navigation and performing the medicalprocedure, e.g., fluoroscopy, video, CT, MR etc. Moreover, in someembodiments, imaging means, such as a distal camera and lens may bemounted at the distal end of the leader 212. Distal end 220 of leader212 may then be navigated to an operative site and tools are deployedthrough a longitudinally-aligned working channel within leader 212 toperform desired procedures. The virtual rail may be maintained duringthe navigation procedure and any subsequent operative procedures. Anynumber of alternative procedures that may require a tool or no tool atall can be performed using the flexible endoscope sliding through thesheath, as the skilled artisan will appreciate.

FIG. 2B illustrates an overhead view of system 200 where anesthesia cart201 is provided towards the head of the patient. Additionally, controlconsole 203 with a user interface is provided to control sheath 210,endoscope leader 212, and the associated arms 202 and 204 and tool bases206 and 208 (see FIG. 2A).

FIG. 2C shows an angled view of system 200 in FIG. 2A. Tool modules 206and 208 with associated sheath 210 and leader 212 are attached to arms202 and 204 and arranged in a 180 degree virtual rail. The arms areshown on a single cart, which provides added compactness and mobility.Tool bases 206 and 208 have pulley systems or other actuation systems totension tendons in sheath 210 and leader 212 to steer their respectivedistal ends. Tool bases 206 and 208 may provide other desired utilitiesfor the sheath and endoscope, such as pneumatic pressure, electrical,data communication (e.g., for vision), mechanical actuation (e.g., motordriven axles) and the like. These utilities may be provided to the toolbases through the arms, from a separate source or a combination of both.

FIGS. 2D and 2E illustrate alternative arrangements of arms 202 and 204showing the versatility of the robotic surgical system in accordancewith embodiments of the present invention. In FIG. 2D, arms 202 and 204may be extended to position the instrument (comprising sheath 210 andleader 212) to enter the mouth of patient 211 at 75 degrees fromhorizontal, while still maintaining a 180 degree virtual rail. This maybe done during the procedure if required to accommodate spacerequirements within the room. The 75 degree angle was chosen fordemonstrative purposes, not by way of limitation.

FIG. 2E shows an alternative arrangement of arms 202 and 204 where thetool bases 206 and 208 are aligned to create a virtual rail with a 90degree angle, in accordance with an embodiment of the present invention.In this embodiment, the instrument (comprising sheath 210 and leader212) enters the mouth of patient 213 at 75 degrees from horizontal. Toolbases 206 and 208 are aligned such that the leader 212 bends 90 degreesat tool base 206 prior to entering the mouth of patient 213. Tofacilitate the bend of leader 212, a rigid or semi-rigid patientinterface, such as a tube, may be used to ensure smooth extension andretraction of the leader 212 within sheath 210. In some embodiments, anadditional mechanical or robotic arm may be used to hold the patientinterface in a fixed position relative to the patient.

Extension and retraction of leader 212 within sheath 210 may becontrolled by moving tool base 208 either closer or farther from toolbase 206 along the linear path tracked by leader 212. Extension andretraction of sheath 210 may be controlled by moving tool base 206closer or farther from patient 213 along the linear path tracked bysheath 210. To avoid unintended extension or retraction of leader 212while extending or retracting sheath 210, tool base 208 may also bemoved along a linear path parallel to sheath 210.

Virtual rails are useful in driving both rigid instrument and flexibleinstruments, and especially where there are telescoping requirements.The use of a virtual rail is not limited to a single rail but canconsist of multiple virtual rails where the arms act in concert tomaintain the individual virtual rails in performance of one or moreprocedures.

FIG. 3A illustrates an overhead view of a system with multiple virtualrails, in accordance with an embodiment of the present invention. InFIG. 3A, robot arms 302, 304 and 306 respectively hold tool bases 308,310, and 312. Tool bases 308 and 310 may be operatively coupled toflexible tool 314 and tool 316. Tool 314 and tool 316 may be atelerobotically-controlled flexible endoscopic instruments. Tool base312 may be operatively coupled to a dual lumen sheath 318, where eachlumen receives tools 314 and 316. Arms 302 and 304 may each maintain avirtual rail with robotic arm 306, and movements of all three arms maybe coordinated to maintain virtual rails and move tools 314, 316 andsheath 318 relative to each other and the patient.

FIG. 3B illustrates the use of the robotic surgery system from FIG. 3Awith an additional robotic arm 320 and associated tool base 322 and tool324. In this embodiment sheath 325 may have three lumens. Alternatively,sheath 325 may comprise more than one sheath to provide access to tools314, 316, and 324. As will be appreciated, the ability to increase orreduce the number of arms with associated modules and instrumentspermits a great number and flexibility of surgical configurations,which, in turn, permits re-purposing of expensive arms and use ofmultiple relatively-inexpensive modules to achieve great versatility atreduced expense.

To create the virtual rail, a plurality of arms and/or platforms may beutilized. Each platform/arm must be registered to the others, which canbe achieved by a plurality of modalities including, vision, laser,mechanical, magnetic, or rigid attachment. In one embodiment,registration may be achieved by a multi-armed device with a single baseusing mechanical registration. In mechanical registration, an embodimentmay register arm/platform placement, position, and orientation based ontheir position, orientation and placement relative to the single base.In another embodiment, registration may be achieved by a system withmultiple base using individual base registration and “hand-shaking”between multiple robot arms. In embodiments with multiple bases,registration may be achieved by touching together arms from differentbases, and calculating locations, orientation and placement based on (i)the physical contact and (ii) the relative locations of those bases. Insome embodiments, registration targets may be used to match the positionand orientations of the arms relative to each other. Through suchregistration, the arms and instrument driving mechanisms may becalculated in space relative to each other. The skilled artisan will beable to use many different methods to register the robotic platforms.

System Modularity & Flexibility.

Returning to FIG. 1 , robotic surgical system 100 may be configured in amanner to provide a plurality of surgical system configurations, such asby changing IDM 117 and tool 118 (also known as an end effector). Thesystem may comprise one or more mobile robotic platforms staged atdifferent locations in the operative room, or at a convenient nearbylocation. Each platform may provide some or all of power, pneumaticpressure, illumination sources, data communication cables and controlelectronics for a robotic arm that is coupled to the platform, and themodule may draw from these utilities as well. System 100 mayalternatively have multiple arms 102 mounted on one or more mobile carts101, or the arms may be mounted to the floor in order to provide aplurality of surgical configurations.

In addition to multiple arms and platforms, certain embodiments of thepresent invention are designed to readily exchange between multiplemodules or end effector mechanisms. Various surgical procedures or stepswithin a procedure may require the use of different modules and theassociated instrument sets, for example, exchanging between differentsized sheath and endoscope combinations. The interchangeability allowsthe system to reconfigure for different clinical procedures oradjustments to surgical approaches.

FIG. 4A illustrates an embodiment compatible with interchangeablemodules and instruments. Surgical system 400, like those shown anddescribed previously, has one or more robotic arms 401 to which IDM ormodule 402 with tool or instrument 403 is attached. Modules 402′ and402″, and associated instruments 403′ and 403″, can be exchanged ontorobotic arm 401 or picked up by a different robotic arm (not shown) tobe used alone in concert with another module. Each module is a dedicatedelectromechanical system which is used to drive various types ofinstruments for specified procedures. To drive instruments, each IDM ormodule may comprise an independent drive system, which may include amotor. They may contain sensors (e.g., RFID) or memory chips that recordtheir calibration and application related information. A systemcalibration check may be required after a new mechanism is connected tothe robot arm. In some embodiments, a module may control an associatedsheath, catheter leader, or flexible endoscope.

In FIG. 4A, system 400 may exchange IDM 402 for IDMs 402′ and 402″ byitself through the use of global registration and sensors. In someembodiments, IDMs 402″ and 403″ are stored on system cart 404 atpredetermined “docking stations” which are configured withidentification and proximity sensors. Sensors at these stations may makeuse of technologies such as RFID, optical scanners (e.g., bar codes),EEPROMs, and physical proximity sensors to register and identify whichIDMs are “docked” at the docking station. As robotic arm 401 and the IDMdocking stations reside on system cart 404, the identification andproximity sensors allow the IDMs that are resting in the dockingstations to be registered relative to the robotic arm(s). Similarly, inembodiments with multiple arms on a single system cart, multiple armsmay access the IDMs on the docking station using the combination ofregistration system and sensors discussed above.

FIG. 4B shows two different perspectives on exchange mechanisms 404 and405 that may be used to exchange and attach modules 402 to robotic arm401. Exchange mechanisms 404 and 405 provide the connection between amodule, such as module 402 in FIG. 4A, and a robotic arm, such asrobotic arm 401 in FIG. 4A. In some embodiments, the mechanism 404 maybe the interface on a module, such as an instrument driving mechanism,for connection to mechanism 405, which may be the interface on a roboticarm. Mechanism 404 may provide a mechanism interface 411 for connectingflange 407 into ring 408 of mechanism 405. Similarly, the interface mayprovide for transmitting power (409), fiber optics, data connections,pneumatic connections (410, 411), motors to drive pulley systems tocontrol a tool, such as a sheath and flexible endoscope. As describedfor the sheath and flexible endoscope embodiment, the sheath andflexible endoscope would be operatively coupled to the exchangemechanism.

FIGS. 5A-5D illustrate a mechanism changer interface in a roboticsystem, in accordance with an embodiment of the present invention. FIG.5A specifically illustrates an implementation of a mechanism changerinterface coupled to a robotic arm in a robotic system, in accordancewith an embodiment of the present invention. As shown in FIG. 5A, thedistal portion of robotic arm 500 comprises an articulating joint 501coupled to a “male” mechanism changer interface 502. Articulating joint501 provides an additional degree of freedom with respect tomanipulating an instrument device mechanism (not shown) that isconfigured to couple to robotic arm 500. Male mechanism changerinterface 502 provides a male connector interface 503 that provides astrong, physical connection to the reciprocal female receptacleconnector interface on the IDM (not shown). The spherical indentationson the male connector interface 503 physically couple to reciprocalindentations on the female receptacle interface on the IDM. Thespherical indentations may be extended when pneumatic pressure isconveyed along robotic arm 500 into male mechanism changer interface502. The male mechanism changer interface 502 also provides connections504 for transferring for pneumatic pressure to the IDM. Additionally,this embodiment of the mechanism changer interface provides foralignment sensors 505 that ensure that the male mechanism changerinterface 502 and its reciprocal female interface are properly aligned.

FIG. 5B illustrates an alternative view of male mechanism changerinterface 502 separated from robotic arm 500. As discussed with respectto FIG. 5A, male mechanism changer interface 502 provides for aflange-like male connector interface 503, pneumatic connectors 504, andalignment sensors 505. Additionally, an electrical interface 506 forconnecting electrical signals to the reciprocal interface on the IDM(not shown).

FIG. 5C illustrates a reciprocal female mechanism changer interfacecoupled to an instrument device manipulator for connecting with malemechanism changer interface 502 from FIGS. 5A and 5B. As shown in FIG.5C, instrument device manipulator 507 is coupled to a female mechanismchanger interface 508 that is configured to connect to male mechanismchanger interface 502 on robotic arm 500. Female mechanism changerinterface 508 provides for female receptacle interface 509 that isdesigned to couple to the flange-like male connector interface 503 ofmale mechanism changer interface 502. The female receptacle interface509 also provides a groove to grip the spherical indentations on themale connector interface 503. When pneumatic pressure is applied,spherical indentations on male connector 503 are extended, and maleconnector 503 and receptacle interfaces 509 securely couple the IDM 507to the robotic arm 500. Reciprocal female mechanism changer interface508 also provides with pneumatic connectors 510 to accept the pneumaticpressure conveyed from connectors 504.

FIG. 5D illustrates an alternative view of female mechanism changerinterface 508 from FIG. 5C. As discussed earlier, reciprocal mechanismchanger interface 508 contains a receptacle interface 509, pneumaticconnectors 510 for interfacing with mechanism changer interface 502 onrobotic arm 500. In addition, mechanism changer interface 508 alsoprovides for an electrical module 511 for transmitting electricalsignals—power, controls, sensors—to module 506 in mechanism changerinterface 502.

FIGS. 6-9B illustrate additional, interchangeable modules that may beoperated using system 400 from FIG. 4 . FIG. 6 illustrates an embodimentof the present invention that uses a single port laparoscopic instrument601 connected through an instrument interface 602 on a single roboticarm 603 that is directed at the abdomen 604 of a patient 605.

FIG. 7 illustrates an embodiment of the present invention with two setsof robotic subsystems 701 and 704, each with a pair of robotic arms 702,703 and 705, 706 respectively. Connected through instrument interfacesat the distal end of each robotic arm are laparoscopic instruments 707,708, 709, 710, respectively, all instruments working together to performthe procedures in an individual patient 711.

FIG. 8A illustrates an embodiment of the present invention with asubsystem 801 with a single robotic arm 802, where a microscope tool 804connected to the robotic arm 802 through an instrument interface 803. Insome embodiments, the microscopic tool 804 may be used in conjunctionwith a second microscope tool 805 used by a physician 806 to aid invisualizing the operational area of a patient 807.

FIG. 8B illustrates an embodiment of the present invention wheresubsystem 801 from FIG. 8A may be used in conjunction with subsystem 808to perform microsurgery. Subsystem 808 provides robotic arms 809 and810, each with microsurgical tools 811 and 812 connected throughinstrument interfaces on each respective arm. In some embodiments, theone or more robotic arms can pick up and exchange tools at a table orother suitable holding mechanism within reach of the robotic arm, suchas a docking station. In FIG. 8A, shows the interchangeable modules arestored on the side of the cart on which the robotic arm is mounted.

Robotic Catheter Design.

In a preferred embodiment, robotic system 100 from FIG. 1 may drive atool customized for various surgical procedures, such as roboticcatheter 118. FIG. 9 is an illustration of a robotic catheter that maybe used in conjunction with a robotic system 100 from FIG. 1 , inaccordance with an embodiment of the present invention. Robotic catheter900 may be arranged around nested longitudinally-aligned tubular bodies,referred to as a “sheath” and a “leader”. The sheath 901, the tubulartool with the larger outer diameter, may be comprised of a proximalsheath section 902, a distal sheath section 903, and a central sheathlumen (not shown). Through signals received in the sheath base 904, thedistal sheath portion 903 may be articulated in the operator's desireddirection. Nested within the sheath 901 may be a leader 905 with asmaller outer diameter. The leader 905 may comprise a proximal leadersection 906 and a distal leader section 907, and a central workingchannel. Similar to sheath base 904, leader base 908 controlsarticulation of the distal leader section 907 based on control signalscommunicated to leader base 908, often from the IDMs (e.g., 117 fromFIG. 1 ).

Both the sheath base 904 and leader base 908 may have similar drivemechanisms, to which control tendons within sheath 901 and leader 905are anchored. For example, manipulation of the sheath base 904 may placetensile loads on tendons in the sheath 901, therein causing deflectionof distal sheath section 903 in a controlled manner. Similarly,manipulation of the leader base 908 may place tensile loads on thetendons in leader 905 to cause deflection of distal leader section 907.Both the sheath base 904 and leader base 908 may also contains couplingsfor the routing of pneumatic pressure, electrical power, electricalsignals or optical signals from the IDMs to the sheath 901 and leader904.

Control tendons within the sheath 901 and leader 905 may be routedthrough the articulation section to an anchor positioned distal to thearticulation section. In a preferred embodiment, the tendons withinsheath 901 and leader 905 may consist of a stainless steel controltendon routed through a stainless steel coil, such as a coil pipe. Oneskilled in the arts would appreciate that other materials may be usedfor the tendons, such as Kevlar, Tungsten and Carbon Fiber. Placingloads on these tendons causes the distal sections of sheath 901 andleader 905 to deflect in a controllable manner. The inclusion of coilpipes along the length of the tendons within the sheath 901 and leader905 may transfer the axial compression back to the origin of the load.

Using a plurality of tendons, the robotic catheter 900 has the abilityto navigate lumens within the human body with ease by providing aplurality of degrees of freedom (each corresponding to an individualtendon) control at two points—distal sheath section 903 and distalleader section 907—along its length. In some embodiments, up to fourtendons may be used in either the sheath 901 and/or leader 905,providing up to eight degrees of freedom combined. In other embodiments,up to three tendons may be used, providing up to six degrees of freedom.

In some embodiments, the sheath 901 and leader 905 may be rolled 360degrees, providing for even more tool flexibility. The combination ofroll angles, multiple degrees of articulation, and multiple articulationpoints provides the surgeon with a significant improvement to theinstinctive control of the device as it navigates a tortuous path withinthe human body.

Sheath and Endoscope Structure.

FIGS. 10A, 10B, 10C, 11A, and 11B provide details of a sheath (similarto that of sheath 210 described above) and a flexible endoscope (similarto that of flexible endoscope 212 described above) in accordance with anembodiment of the present invention. FIG. 10A shows sheath 1000 withdistal end 1001 and proximal end 1002 and lumen 1003 running between thetwo ends. Lumen 1003 is preferably sized to slidingly receive a flexibleendoscope (such as endoscope 1100 from FIGS. 11A and 11B). Sheath 1000has walls 1004 with tendons 1005 and 1006 running inside the length ofwalls 1004 of sheath 1000. Tendons 1005 and 1006 slidingly pass throughconduits 1007 and 1008 in walls 1004 and terminate at distal end 1001.In some embodiments, the tendons may be formed from steel. Appropriatetensioning of tendon 1005 compresses distal end 1001 towards conduit1007, while minimizing bending of the helixed section 1010. Similarly,appropriate tensioning of tendon 1006 compresses distal end 1001 towardsconduit 1008. In some embodiments, lumen 1003 may not be concentric withsheath 1000.

Tendons 1005 and 1006 and associated conduits 1007 and 1008 from sheath1000 from FIG. 10A preferably do not run straight down the length ofsheath 1000, but helix along a helixed section 1010 and then runlongitudinally straight (i.e., approximately parallel to the neutralaxis) along distal section 1009. It will be appreciated that helixedsection 1010 may begin from the proximal end of distal section 1009extending proximally down sheath 1010 and may terminate at any desiredlength for any desired or variable pitch. The length and pitch ofhelixed section 1010 is determined based on the desired properties ofsheath 1000, taking into account desired flexibility of the shaft, andincreased friction in the helixed section 1010. Tendons 1005 and 1006run approximately parallel to central axis 1011 of sheath 1000 when notin the helixed section, such as the proximal section of the endoscope1000.

In some embodiments, the tendon conduits may be at ninety degrees toeach other (e.g., 3-, 6-, 9- and 12-o'clock). In some embodiments, thetendons may be spaced one hundred and twenty degrees from each other,e.g., three total tendons. In some embodiments, the tendons may be notbe equally spaced. In some embodiments, they may be all to one side ofthe central lumen. In some embodiments, the tendon count may differ fromthree or four.

FIG. 10B shows a three-dimensional illustration of an embodiment ofsheath 1000 with only one tendon for the purpose of clarifying thedistinction between non-helixed section 1009 and a variable pitchhelixed section 1010. While one tendon may be used, it is preferred touse multiple tendons. FIG. 10C shows a three-dimensional illustration ofan embodiment of sheath 1000 with four tendons extending along distalsection 1009, helixed section 1010 and then proximal to helixed section1010.

FIG. 11A shows a flexible endoscope 1100 with distal end 1101 andproximal end 1102, that may be sized to slidingly reside within thesheath 1000 from FIGS. 10A-10C. Endoscope 1100 may include at least oneworking channel 1103 passing through it. Proximal end 1002 of sheath1000 and proximal end 1102 of flexible endoscope 1100 are, respectively,operatively connected to modules 206 and 208 from FIG. 2 respectively.Tendons 1104 and 1105 slidingly pass through conduits 1106 and 1107respectively in walls 1108 and terminate at distal end 1101.

FIG. 11B shows the distal end 1101 of flexible endoscope 1100, anexemplary embodiment, that has imaging 1109 (e.g., CCD or CMOS camera,terminal end of imaging fiber bundle etc.), light sources 1110 (e.g.,LED, optic fiber etc.) and may include at least one working channelopening 1103. Other channels or operating electronics 1106 may beprovided along flexible endoscope 1100 to provide various knowncapabilities at the distal end, such as wiring to camera, insufflation,suction, electricity, fiber optics, ultrasound transducer, EM sensing,and OCT sensing.

In some embodiments, the distal end 1101 of endoscope 1100 may include a“pocket” for insertion of a tool, such as those disclosed above. In someembodiments, the pocket may include an interface for control over thetool. In some embodiments, a cable, such as an electrical or opticalcable, may be present in the endoscope in order communicate with theinterface.

In some embodiments, sheath 1000 from FIG. 10A and flexible endoscope1100 from FIG. 11A both, preferably, may have robotically controlledsteerable distal ends. The structure of sheath 1000 and flexibleendoscope 1100 enabling this control is thus substantially the same forboth, and thus discussion for the construction of sheath 1000 will belimited to that of the sheath 1000 with the understanding that the sameprinciples apply to the structure of the flexible endoscope 1100.

Therefore, tendons 1104 and 1105 and associated conduits 1106 and 1107from the endoscope 1100 from FIG. 11A do not run longitudinally straight(i.e., approximately parallel to the neutral axis) down the length ofendoscope 1100, but helix along different portions of endoscope 1100. Aswith the helixed tendons and conduits in sheath 1000, the helixedsections of endoscope 1100 may be determined based on the desiredproperties of the endoscope, taking into account desired flexibility ofthe shaft, and increased friction in the helixed section. Tendons 1104and 1105 run approximately parallel to central axis of endo scope 1000when not in the helixed section.

The purpose of the helixed section, as described more fully below, is tohelp isolate the bending to the distal section, while minimizing bendingthat occurs along the shaft proximal to the distal section. In someembodiments of the present invention, the helix pitch of the conduits insheath 1000 and endoscope 1100 may be varied along the length of thehelixed section, which, as more fully described below will alter thestiffness/rigidity of the shaft.

The use of helixed conduits and helixed tendons in sheath 1000 andendoscope 1100 present significant advantages over previous flexibleinstruments without helixed conduits, particularly when navigatingnon-linear pathways in anatomical structures. When navigating curvedpathways, it is preferable for sheath 1000 and endoscope 1100 to remainflexible over most of the lengths thereof, and to have a controllablysteerable distal end section, while also minimal secondary bending ofthe instrument proximal to the distal bending section. In previousflexible instruments, tensioning the tendons in order to articulate thedistal end resulted in unwanted bending and torquing along the entirelength of the flexible instrument, which may be referred to as“muscling” and “curve alignment” respectively.

FIGS. 12A to 12C illustrates how the prior flexible instruments exhibitundesirable “muscling” phenomenon when tendons are pulled. In FIG. 12A,a previous flexible instrument 1200 may have four tendons or controlwires along the length of the instrument 1200 that run approximatelyparallel to the neutral axis 1201. Only tendons 1202 and 1203 are shownin cross section traveling through conduits 1204 and 1205 (also known ascontrol lumens) in the shaft wall, each of which are fixed connected toa control ring 1206 on the distal end of the instrument 1200. Instrument1200 is intentionally designed to have a bending section 1207 and shaft1207. In some flexible instruments, the shaft 1208 may incorporatestiffer materials, such as stiffeners.

FIG. 12B illustrates an idealized articulation of the bending section1207. By pulling or exerting tension on tendon 1203, articulation ofonly the distal bending section 1207 results an amount represented by ϕ,where the length difference at the proximal ends of tendons 1202 and1203 would be a f(ϕ). In contrast, the shaft 1208 remains straight alongthe neutral axis 1201. This is achieved by having a proximal region 1208of a significantly higher stiffness than the distal region of 1207.

FIG. 12C illustrates the real world result from tensioning tendon 1203.As shown in FIG. 12C, pulling tendon 1203 results in compressive forcesalong the entire length of the shaft as the tension is non-localized. Inan idealized situation, were tendon 1203 along the neutral axis 1201,the entire compressive load would transmit equally down the central axisand most or all bending would occur at the bending section 1207.However, where the tendon 1203 runs along the periphery of the shaft1208, such as in instrument 1200, the axial load is transferred off theneutral axis 1201 in the same radial orientation of the neutral axiswhich creates a cumulative moment along the neutral axis. This causesthe shaft 1208 to bend (depicted as θ), where the bend in the shaft 1208will be in the same direction as the bend in the bending section 1207.The length along conduit 1204 and conduit 1205 must change as theinstrument 1200 and distal bend section 1207 bend. The amount tendons1202 and 1203 extend from the proximal end is f(ϕ,θ), as tendon 1203will need to shorten and tendon 1202 will need to lengthen. Thisphenomenon, where the shaft 1207 and distal bending section 1208 bendfrom pulling tendon 1203, is referred to as “muscling.”

FIG. 12D illustrates the forces that contribute to muscling inthree-dimensions. As shown by FIG. 12D, tensioning tendon 1203 alonginstrument 1200 causes the tendon 1203 to directionally exert forces1212 towards one side of the instrument. The direction of forces 1212reflect that the tension in tendon 1203 causes the tendon to seek tofollow a straight line from the tip of the distal bending section 1207to the base of the shaft 1208, i.e., the lowest energy state asrepresented by the dotted line 1213 in FIG. 12E. As will be appreciated,if the shaft 1208 is rigid (i.e., not susceptible to bending under theapplicable forces), only the distal bending section 1207 will bend.However, in many applications it is not desirable to make the shaftrigidity sufficiently different from the distal end to adequatelyminimize the muscling phenomenon.

FIGS. 12F to 12I illustrate how previous flexible instruments sufferfrom curve alignment phenomenon during use in non-linear pathways. FIG.12F shows a previous flexible instrument 1200 at rest within anon-linear path, represented by having a bend t along the shaft 1208 ofinstrument 1200. For example, this may result from the instrumentnavigating past a bend in the bronchial lumens. Due to the non-linearbend, tendons 1202 and 1203 in instrument 1200 need to lengthen orshorten at the proximal end by a length to accommodate the non-linearbend, which length is represented by F(τ). Extension and compressiveforces exist on the lumens/conduits at the top and bottom of the bend,as depicted by arrows 1209 (extension forces) and 1210 (compressiveforces) respectively. These forces exist because the distance along thetop of the bend is longer than the neutral axis, and the distance alongthe inside of the bend is shorter than the neutral axis.

FIG. 12G illustrates the mechanics of articulating the distal bendingsection 1207 of the instrument 1200 in the same direction as bend t,where one would pull tendon 1203. This results in compressive forcesalong the length of the flexible instrument (as previously described),and tendon 1203 also exerts downward forces against the non-linearconduit through which it passes, which applies an additive compressionin the shaft 1208 previously compressed by the anatomical tortuosity.Since these compressive leads are additive, the shaft 1208 will furtherbend in the same direction as the distal bending section 1207. Theadditional compressive force along the non-linear conduit is highlyundesirable because: (i) it forces the flexible instrument against theanatomy causing potential injury; (ii) potential for injury distractsthe operator because he/she has to constantly monitor what the shaft isdoing, when he/she should be able to “assume” the anatomy is governingthe profile of the instrument shaft; (iii) it is an inefficient way tobend the instrument, (iv) it is desired to isolate bending at the distalsection to aid in predictability and controllability (i.e., idealinstrument will have bending section that bends as commanded and is nota function of the anatomical non-linear path), and (v) it forces a userto pull on a tendon 1103 an unpredictable additional length (ϕ+θ+τ).

FIG. 12H illustrates a scenario where one desires to articulate thedistal end opposite to bend τ, requiring pulling tendon 1202. Pullingtendon 1202 applies a compressive load 1211 along the top of the curve,which is in contrast to the extension loads for the bend in its restingstate as shown in FIG. 12D. Tendons 1202 will attempt to return to itslowest energy state, i.e., where the compressive load 1211 rests on theinside of the bend t, and cause the shaft 1208 to rotate in thedirection of the arrow 1212 so that the tendon 1202 rests on the insideof the bend τ. As shown in FIG. 12I, the rotation 1212 from tension ontendon 1202 moves the compressive load 1211 to return to the inside ofthe bend and causes the distal bending section 1207 to curl back in thedirection of bend τ, resulting in articulation opposite to thatintended. The tension on tendon 1202, and the ensuing rotation 1212, inpractice returns instrument 1200 to the same state as in FIG. 12G. Thephenomenon where the distal end articulation curves back towards bend tis known as “curve alignment.” It will be appreciated that curvealignment results from the same forces that cause muscling, whereinthose forces result in undesirable lateral motion in the case ofmuscling and undesirable rotational motion in the case of curvealignment. It is noted that the discussions of the theory of musclingand curve alignment is provided not by way of limitation, andembodiments of the present invention are not in any way limited by thisexplanation.

The preferred embodiment disclosed in FIGS. 10 and 11 substantiallyresolves the muscling and curve alignment phenomena through theprovision of helixed section 1010. As shown in FIG. 12J, helixing thecontrol lumens around instrument 1200, such as in helixed section 1010from FIGS. 10B and 10C, radially distributes compressive loads 1214 froma single tendon 1215 around instrument 1200. Because a tensioned tendon1215 symmetrically transmits the compressive load 1214 in multipledirections around the neutral axis, the bending moments imposed on theshaft are also symmetrically distributed around the longitudinal axis ofthe shaft, which counterbalance and offset opposing compressive andtensile forces. The distribution of the bending moments results inminimal net bending and rotational forces, creating a lowest energystate that is longitudinally parallel to the neutral axis, asrepresented by the dotted line 1216. This eliminates or substantiallyreduces the muscling and curve alignment phenomena.

In some embodiments, the pitch of helixing can be varied to affectfriction and the stiffness of the helixed section. For example, thehelixed section 1010 may be shorter to allow for a larger non-helixedsection 1009, resulting in a larger articulating section and possiblyless friction.

Helical control lumens, however, create several trade-offs. Helicalcontrol lumens still do not prevent buckling from tension in thetendons. Additionally, while muscling is greatly reduced,“spiraling”—the curving of the shaft into a spiral, spring-like patterndue to tension in the tendons—is very common. Moreover, helical controllumens requires compensation for additional frictional forces as thetendon travels through the lumen for longer distances.

FIG. 13 illustrates the structure of a flexible endoscopic device withan axially stiff tube within a lumen, in accordance with an embodimentof the present invention. In FIG. 13 , a section of an endoscopic devicehas a single lumen 1301 with a pull wire 1302 wrapped in a helicalpattern around the shaft 1300. Inside the lumen, an axially stiff tube1303 “floats” around the pull wire 1302 and within the lumen 1301.Anchored at the beginning and end of the helical portion of the shaft1300, the floating tube 1303 extends and compresses in response totension in pull wire 1302 and external tortuosity, relieving the wallsof lumen 1301 from the extension and compression forces. In someembodiments, the tube 1303 may be anchored by pull rings at thebeginning and end of the lumen. Alternatively, tube 1303 may be anchoredusing solder, welding, gluing, bonding, or fusing methods to thebeginning and end of the lumen. In some embodiments, geometricengagement, such as flared geometries, may be used to anchor tube 1303.In various embodiments, the tube 1303 may be formed from hypodermictubes, coil pipes, Bowden cables, torque tubes, stainless steel tubes,or nitinol tubes.

The embodiment in FIG. 13 may be constructed by fixedly attaching thetubes to a distal end piece and proximal end piece and collectivelytwisting the tubes by rotating either or both end pieces. In thisembodiment, the rotation of the end piece(s) ensures that the tubes arehelixed in the same pitch, manner, and orientation. After rotation, theend pieces may be fixedly attached to the lumen to prevent furtherrotation and restrict changes to the pitch of the helixing.

FIG. 14 illustrates the structure of a helical pattern within a lumen ofa flexible endoscopic device, in accordance with an embodiment of thepresent invention. In FIG. 14 , lumen 1400 contains structures 1401 and1402 that form a helical or spiraled pattern along its walls. Inpreferred embodiments, the structures are formed from materials that areaxially stiff and tube-like in shape. In some embodiments, thestructures may be formed from hypodermic tubes (“hypo tube”), coilpipes, or torque tubes. As shown by structures 1401 and 1402, thestructures may have different starting points along the walls of lumen1400. The materials, composition, and characteristics of structures 1401and 1402 may also be selected and configured for desired stiffness andlength. The pitch of the helical pattern formed by structures 1401 and1402 may also be configured for a desired stiffness and flexibility oflumen 1400. In some embodiments, lumen 1400 may be the main centrallumen of a flexible endoscope, such as endoscope 1100 from FIG. 11 .

Robotic Catheter System.

FIG. 15A illustrates a robotic catheter from a robotic catheter system,in accordance with an embodiment of the present invention. Roboticcatheter 1500 may comprise of a flexible shaft section 1501 proximal toa support base (not shown) and a flexible articulating section 1502coupled to a distal tip 1503. Similar to the leader 1505, roboticcatheter 1500 may be articulated by placing tensile loads on tendonswithin the shaft.

FIG. 15B illustrates an alternative view of robotic catheter 1500 fromFIG. 15A. As shown in FIG. 15B, the distal tip 1503 may comprise aworking channel 1504, four light emitting diodes 1505, and a digitalcamera 1506. In conjunction with the LEDs 1505, the digital camera 1506may be used, for example, to capture real-time video to assist withnavigation within anatomical lumens. In some embodiments, the distal tip1503 may comprise an integrated camera assembly which houses a digitalimaging means and illumination means.

The working channel 1504 may be used for the passage of intraoperativeinstruments, such as bending flexures for precise articulation at anoperative site. In other embodiments, working channels may beincorporated to provide additional capabilities such as flush,aspiration, illumination or laser energy. The working channel may alsofacilitate the routing of control tendon assemblies and other lumensneeded for the aforementioned additional capabilities. The workingchannel of the robotic catheter may also be configured to deliver avariety of other therapeutic substances. Such substances may becryogenic for ablation, radiation, or stem cells. These substances maybe precisely delivered precisely to a target site using the insertion,articulation, and capability of the robotic catheter of the presentinvention. In some embodiments, the working channel may be as small at1.2 millimeters in diameter.

In some embodiments, an electromagnetic (EM) tracker may be incorporatedinto the distal tip 1503 in order to assist with localization. As willbe discussed later, in a static EM field generator may be used todetermine the location of the EM tracker, and thus distal tip 1503 inreal-time.

Images from camera 1506 may be ideal for navigating through anatomicalspaces. Thus, obscuring of the camera 1506 from internal bodily fluids,such as mucus, may cause problems when navigating. Accordingly, thedistal end 1503 of robotic catheter 1500 may also include means forcleaning the camera 1506, such as means for irrigation and aspiration ofthe camera lens. In some embodiments, the working channel may contain aballoon that may be inflated with fluid around the camera lens andaspirated once the lens was clear.

The robotic catheter 1500 enables the delivery and manipulation of smallinstruments within a small anatomical space. In a preferred embodiment,the distal tip may be miniaturized in order to perform endolumenalprocedures, maintaining an outer diameter of no more than threemillimeters (i.e., nine French).

FIG. 16 illustrates the distal end of a robotic catheter, in accordancewith an embodiment of the present invention. As in FIG. 15A, roboticcatheter 1600 similarly includes a distal end 1601 with an outer casing1602. Casing 1602 may be constructed from a number of materialsincluding stainless steel and polyether ether ketone (PEEK). The distalend 1601 may be packed with a working channel 1603 for slidinglyproviding tool access and control. The distal end 1601 may also providefor an array of light emitting diodes 1604 for illumination with use ofthe camera 1605. In some embodiments, the camera may be part of a largersensor assembly that includes one or more computer processors, a printedcircuit board, and memory. In some embodiments, the sensor assembly mayalso include other electronic sensors such as gyroscopes andaccelerometers (usage discussed later).

Instrument Device Manipulator (IDM).

In some embodiments, the mechanism changer interface may be a simplescrew to secure an associated IDM. In other embodiments, the mechanismchanger interface may be a bolt plate with an electrical connector.

FIG. 17A illustrates a portion of a robotic medical system that includesa manipulator, in accordance with an embodiment of the presentinvention. System 1700 includes a partial view of a robotic arm 1701, anarticulating interface 1702, an instrument device manipulator (“IDM”)1703, and a robotic catheter 1704. In some embodiments, the robotic arm1701 may be only a linkage in a larger robotic arm with multiple jointsand linkages. The articulating interface 1702 couples IDM 1703 torobotic arm 1701. In addition to coupling, the articulating interface1702 may also transfer pneumatic pressure, power signals, controlsignals, and feedback signals to and from the arm 1701 and the IDM 1703.

The IDM 1703 drives and controls the robotic catheter 1704. In someembodiments, the IDM 1703 uses angular motion transmitted via outputshafts in order to control the robotic catheter 1704. As discussedlater, the IDM 1703 may comprise a gear head, motor, rotary encoder,power circuits, control circuits.

Robotic catheter 1704 may comprise a shaft 1709 with a distal tip andproximal end. A tool base 1710 for receiving the control signals anddrive from IDM 1703 may be coupled to the proximal end of the shaft1709. Through the signals received by the tool base 1710, the shaft 1709of robotic catheter 1704 may be controlled, manipulated, and directedbased on the angular motion transmitted via output shafts 1705, 1706,1707, and 1708 (see FIG. 17B) to the tool base 1710 of the roboticcatheter 1704.

FIG. 17B illustrates an alternative view of the robotic medical systemdisclosed in FIG. 17A. In FIG. 17B, the robotic catheter 1704 has beenremoved from the IDM 1703, to reveal the output shafts 1705, 1706, 1707,and 1708. Additionally, removal of the outer skin/shell of IDM 1703reveals the components below the IDM top cover 1711.

FIG. 18 illustrates an alternative view of the independent drivemechanism from FIGS. 17A, 17B with a tension sensing apparatus inaccordance with an embodiment of the present invention. In cutaway view1800 of IDM 1703, parallel drive units 1801, 1802, 1803, and 1804 arethe structurally largest components in the IDM 1703. In someembodiments, from the proximal to the distal end, a drive unit 1801 maybe comprised of a rotary encoder 1806, a motor 1805, and a gear head1807. Drive units 1802, 1803, and 1804 may be constructedsimilarly—comprising of motors, encoders, and gear heads underneath thetop cover 1711. In some embodiments, the motor used in the drive unit isa brushless motor. In other embodiments, the motor may be a directcurrent servo motor.

Rotary encoder 1806 monitors and measures the angular speed of thedriveshaft of motor 1805. In some embodiments, rotary encoder 1806 maybe a redundant rotary encoder. The structure, capabilities, and use ofan appropriate redundant encoder is disclosed in U.S. Provisional PatentApplication No. 62/037,520, filed Aug. 14, 2014, the entire contents ofwhich are incorporated by reference.

The torque generated by the motor 1805 may be transmitted to gear head1807 through a shaft coupled to the rotor of motor 1805. In someembodiments, the gear head 1807 may be attached to the motor 1805 inorder to increase torque of the motor output, at the cost of therotational speed. The increased torque generated by gear head 1807 maybe transmitted into gear head shaft 1808. Similarly, drive units 1802,1803, and 1804 transmit their respective torque out through gear headshafts 1706, 1707, and 1708.

Each individual drive unit may be coupled to a motor mount at its distalend and a strain gauge mount towards its proximal end. For example, thedistal end of drive unit 1801 may be clamped to motor mount 1809 andstrain gauge mount 1810. Similarly, drive unit 1802 may be clamped tomotor mount 1811, while also both being clamped to strain gauge mount1810. In some embodiments, the motor mounts are constructed fromaluminum to reduce weight. In some embodiments, the strain gauge mountsmay be adhered to a side of the drive unit. In some embodiments, thestrain gauge mounts may be constructed from aluminum to reduce weight.

Electrical strain gauges 1812 and 1813 are potted and soldered to thestrain gauge mount 1810 and attached using screws to motor mounts 1809and 1811 respectively. Similarly, a pair of strain gauges (not shown)proximal to drive units 1803 and 1804 are potted and soldered to straingauge mount 1814 and attached to motor mounts 1815 and 1816 respectivelyusing screws. In some embodiments, the electrical strain gauges may beheld in place to their respective motor mount using side screws. Forexample, side screws 1819 may be inserted into motor mount 1809 to holdin place strain gauge 1812. In some embodiments, the gauge wiring in theelectrical strain gauges may be vertically arranged in order to detectany vertical strain or flex in the drive unit which may be measured ashorizontal displacement by the motor mount (1809, 1811) relative to thestrain gauge mount (1810).

The strain gauge wiring may be routed to circuits on the strain gaugemounts. For example, strain gauge 1812 may be routed to circuit board1817 which may be mounted on strain gauge mount 1810. Similarly, straingauge 1813 may be routed to circuit board 1818 which may be also mountedon strain gauge mount 1810. In some embodiments, circuit boards 1817 and1818 may process or amplify the signals from strain gauges 1812 and 1813respectively. The close proximity of circuit boards 1817 and 1818 tostrain gauges 1812 and 1813 helps to reduce the signal to noise ratio inorder to obtain more accurate readings.

FIG. 19A illustrates a cutaway view of the independent drive mechanismfrom FIGS. 17A, 17B, and 18 from an alternate angle. As shown in FIG.19A, a portion of outer shell/skin 1901 has been cut away to reveal theinnards of IDM 1703. As discussed earlier, the drive unit 1801 comprisesof motor 1805, rotary encoder 1806, and gear head 1807. The drive unit1801 may be coupled to the motor mount 1809 and passes through the topcover 1711 through which the output shaft 1705 may be driven at thedesired angular speed and torque. The motor mount 1809 may be coupled toa vertically aligned strain gauge 1812 using side screws. In addition tocoupling to motor mount 1809, the stain gauge 1812 may be potted intothe strain gauge mount 1810. In some embodiments, the output shaft 1705includes a labyrinth seal over a gear head shaft.

FIG. 19B illustrates a cutaway view of the previously discussedindependent drive mechanism in combination with a robotic catheter, inaccordance with an embodiment of the present invention. As shown in FIG.19B, robotic catheter 1704, mounted on IDM 1703, contains pulleys thatare longitudinally aligned with the output shafts of the IDM 1703, suchas pulley 1902 which may be concentric with output shaft 1705. Pulley1902 may be housed inside of a precision cut chamber 1903 within toolbase 1710 such that the pulley 1902 may be not rigidly fixed insidechamber 1903 but rather “floats” within the space in the chamber 1903.

The splines of the pulley 1902 are designed such that they align andlock with splines on output shaft 1705. In some embodiments, the splinesare designed such that there may be only a single orientation for therobotic catheter to be aligned with IDM 1703. While the splines ensurepulley 1902 is concentrically aligned with output shaft 1705, pulley1902 may also incorporate use of a magnet 1904 to position and axiallyhold the floating pulley 1902 in alignment with output shaft 1705.Locked into alignment, rotation of the output shaft 1705 and pulley 1902tensions the pull wires within robotic catheter 1704, resulting inarticulation of shaft 1709.

FIG. 20 illustrates an alternative view of the previously-discussedindependent drive mechanism with pull wires from a robotic catheter inaccordance with an embodiment of the present invention. In someembodiments, the robotic catheter may use pull wires in order toarticulate and control the shaft. In those embodiments, these pull wires2001, 2002, 2003, and 2004 may be tensioned or loosened by the outputshafts 1705, 1706, 1707, and 1708 respectively of the IDM 1703.Accordingly, the pull wires may be robotically controlled via thecontrol circuitry in IDM 1703.

Just as the output shafts 1705, 1706, 1707, and 1708 transfer force downpull wires 2001, 2002, 2003, and 2004 through angular motion, the pullwires 2001, 2002, 2003, and 2004 transfer force back to the outputshafts and thus to the motor mounts and drive units. For example,tension in the pull wires directed away from the output shaft results inforces pulling the motor mounts 1809 and 1811. This force may bemeasured by the strain gauges, such as 1812 and 1813, since the straingauges are both coupled to motor mounts 1809 and 1811 and potted in thestrain gauge mount 1810.

FIG. 21 illustrates a conceptual diagram that shows how horizontalforces may be measured by a strain gauge oriented perpendicular to theforces, in accordance with an embodiment of the invention. As shown indiagram 2100, a force 2101 may directed away from the output shaft 2102.As the output shaft 2102 is coupled to the motor mount 2103, the force2101 results in horizontal displacement of the motor mount 2103. Thestrain gauge 2104, coupled to both the motor mount 2103 and ground 2105,may thus experience strain as the motor mount 2103 causes the straingauge 2104 to flex (causing strain) in the direction of the force 2101.The amount of strain may be measured as a ratio of the horizontaldisplacement of the tip of strain gauge 2104 to the overall horizontalwidth of the strain gauge 2104. Accordingly, the strain gauge 2104 mayultimately measure the force 2101 exerted on the output shaft 2102.

In some embodiments, the assembly may incorporate a device to measurethe orientation of instrument device manipulator 1703, such as aninclinometer or accelerometer. In combination with the strain gauges,measurements from the device may be used to calibrate readings from thestrain gauges, since strain gauges may be sensitive to gravitationalload effects resulting from their orientation relative to ground. Forexample, if instrument device manipulator 1703 is oriented on its side,the weight of the drive unit may create strain on the motor mount whichmay be transmitted to the strain gauge, even though the strain may notresult from strain on the output shafts.

In some embodiments, the output signals from the strain gauge circuitboards may be coupled to another circuit board for processing controlsignals. In some embodiments, power signals are routed to the driveunits on another circuit board from that of processing control signals.

As discussed earlier, the motors in drive units 1801, 1802, 1803, and1804 ultimately drive output shafts, such as output shafts 1705, 1706,1707, and 1708. In some embodiments, the output shafts may be augmentedusing a sterile barrier to prevent fluid ingress into the instrumentdevice manipulator 1703. In some embodiments, the barrier may make useof a labyrinth seal (1905 from FIG. 19A) around the output shafts toprevent fluid ingress. In some embodiments, the distal end of the gearhead shafts may be covered with output shafts in order to transmittorque to a tool. In some embodiments, the output shafts may be clad ina steel cap to reduce magnetic conductance. In some embodiments, theoutput shafts may be clamped to the gear head shafts to assist transferof torque.

Instrument device mechanism 1703 may also be covered in a shell or skin,such as outer shell/skin 1901. In addition to being aestheticallypleasing, the shell provides fluid ingress protection during operation,such as during medical procedures. In some embodiments, the shell may beconstructed using cast urethane for electromagnetic shielding,electromagnetic compatibility, and electrostatic discharge protection.

In an embodiment of the present invention, each of those output shaftsin individually tension may pull wires in a robotic catheter that makesuse of steerable catheter technology. Tensile force in the pull wiresmay be transmitted to the output shafts 1705, 1706, 1707 and 1708 anddown to a motor mount, such as motor mounts 1809 and 1811.

Sheath & Endoscope Manufacture.

In the preferred embodiment, the sheath and endoscope devices areconstructed using steerable catheter construction methodologies.Traditionally, steerable catheters have been manufactured by braidingwires or fibers, i.e., braid wire, around a process mandrel with pulllumens in a braiding machine, i.e., braider and a polymer jacket appliedover the braid wires. During manufacture, a process mandrel would betypically inserted into a feed tube of a braider that was coupled to abraid cone support tube and braid cone holder. Using a puller with atread, the process mandrel would be advanced through the feed tube. Asthe process mandrel progressed, it would eventually emerge through acenter hole in a nose cone. The nose cone provided a round, smooth shapeon which the braid wire from the surrounding horn gears may easily slidearound the mandrel during the braiding process. The nose cone wastypically held in a position that was fixed axially and radiallyrelative to the braid cone holder using a set screw keyed to the braidcone holder. As the process mandrel was pulled through the nose cone,the horn gears translate and rotate around the mandrel to braid thebraid wire around the mandrel in a pre-determined pattern and density.

FIG. 22 illustrates a flowchart for a method of constructing a catheterwith helixed lumens, in accordance with an embodiment of the presentinvention. To start, in step 2201, a main process mandrel may beselected to create a cavity in the catheter for a central lumen that maybe used a working channel. Supplemental mandrels may be selected tocreate cavities in the wall of the catheter for use as control (pull)lumens. The main process mandrel may exhibit larger outer diameters (OD)than the supplemental mandrels to reflect the relative size differentialbetween a working channel and pull lumens. The supplemental mandrels maybe constructed a metal or thermoset polymer that may or may not becoated with a lubricious coating, such as PTFE.

In step 2202, the main process mandrel may be inserted into a feed tubeof a braider that rotates relative to a fixed braid cone support tubeand braid cone holder. Similarly, the supplemental mandrels may also beinserted into the feed tube in parallel fashion to the main processmandrel. In traditional catheter construction, smaller supplementalmandrels are passed through the center of the horn gears for braiding.

In step 2203, using a puller with a tread, the main process mandrel maybe advanced through the feed tube. As the main process mandrelprogresses, it eventually emerges through a center hole in a nose cone.

Similarly, the supplemental mandrels are advanced through to also emergethrough outer holes in the nose cone. This contrasts with traditionalcatheter construction, where supplemental mandrels are typicallyadvanced through separate feed tubes to emerge from the center of thehorn gears.

In step 2204, the main process mandrel and supplemental mandrels arebraided together using braid wire as they emerge through the nose cone.The nose cone provides a round, smooth shape on which the braid wirefrom the surrounding horn gears may easily slide around the main processmandrel during the braiding process. As both the main process mandreland supplemental mandrels emerge from the nose cone, the nose conerotates, ensuring that the supplemental mandrels in the outer holes arebraided in a spiraled fashion around the main process mandrel. As themain process mandrel and supplemental mandrels are being braidedtogether, the horn gears translate and rotate to lay braid wire aroundboth the main process mandrel and supplemental mandrels at apre-determined pattern and density.

This method of braiding is significantly different from traditionalmethods of catheter construction, where the nose cone is typically heldin a position that is radially fixed relative to the braid cone holderusing a set screw keyed to the braid cone holder. Thus, specializedhardware is required for the braiding process in order to manufacturecatheters with helical control lumens.

In step 2205, upon completion of the braided process, a polymer coatingor jacket may be sheathed, heated, and bonded to the braiding composite.The polymer coating may also be applied in an over-extrusion or afilm-cast process. In step 2206, after bonding, the mandrels may beremoved from the braided composite to create a central lumen or workingchannel (main process mandrel) for camera and light tools, and severalcontrol lumens (supplemental mandrels) for steering control. Havingremoved the mandrels, the braided composite may be finished forcompletion (2207).

In traditional steerable catheter construction, smaller supplementalmandrels are passed through the center of the horn gears for braidingonto the main process mandrel. The supplemental mandrels, sometimesconstructed from Teflon-coated polyimide, may be braided onto the mainprocess mandrel as it is pulled through the nose cone. Alternatively, itis known in the art that the supplemental mandrels may be passed throughsmall holes in the nose cone that surround the center hole. As the mainprocess mandrel is pulled through the nose cone, the smaller,supplemental mandrels may be braided to the main process mandrel as theyare pulled from the nose cone.

In order to hold the supplemental mandrels in place, a second layer ofbraid wire is typically laid onto the main process mandrel afterapplying the supplemental mandrels. Upon completion of the braidedprocess, a polymer coating or jacket may be sheathed, heated, and bondedto the braiding composite. After bonding, the mandrels are typicallyremoved from the braided composite to create a central lumen (mainprocess mandrel) for camera and light tools, and several control lumens(supplemental mandrels) for steering control. This method of manufactureresults in endoscopes with control lumens that are longitudinallyparallel to the neutral axis. As discussed earlier, catheter-likeendoscopes with tension on tendons in longitudinally parallel lumensexhibit muscling and curve alignment phenomena.

Accordingly, specialized hardware is required for the braiding processin order to manufacture catheter-like endoscopes with helixed controllumens. One such piece of hardware is a specialized rotating nose conethat is fixedly coupled to a rotating feed tube, or “hypotube” in someembodiments. FIG. 23 illustrates a specialized nose cone formanufacturing helical lumens in a flexible sheath, catheter, and/orendoscope, in accordance with an embodiment of the present invention.Rotating the nose cone 2300 at the same time that the main processmandrel 2301 is pulled through the nose cone 2300 allows forsupplemental mandrels 2302, 2303, and 2304 to be applied in a helicalpattern around the mandrel 2301 through supplemental holes 2305, 2306,and 2307 respectively that surround the center hole 2308, similar to howthe horn gears braid the braid wire around the main process mandrel2301.

FIG. 24 illustrates a system for manufacturing a flexible sheath andendoscope in accordance with an embodiment of the present invention. Insystem 2400, the nose cone 2401 may be fixedly coupled to a rotatingfeed tube 2402 using a set screw that holds the nose cone 2401 in afixed position relative to the feed tube 2402. Thus, nose cone 2401rotates as the feed tube 2402 rotates. In contrast, traditional systemstypically use a set screw to fixedly couple the nose cone 2401 to thebraid cone support holder 2405, which does not rotate. The center hole2403 of the nose cone 2401 may be aligned with the rotating feed tube2402 in order to smoothly pull the main process mandrel 2404 throughboth structures. In contrast, traditional systems used a set screw tofixed couple the nose cone 2401 to the braid cone support holder 2405.In some embodiments, the rotating feed tube 2402 has an outside diameterless than the interior diameter of the braid cone support tube 2406,also known as a mandrel guide tube, and an interior diameter larger thanthe circumferential space of the center hole 2403 of the nose cone 2401.The rotating feed tube 2402 may generally be large enough for the mainprocess mandrel 2404 and the supplemental mandrels to be passed throughto the nose cone 2401 without entanglement. In some embodiments, therotating feed tube 2402 is long enough to pass through the center of thehorn gears of the braider. In some embodiments, the rotating feed tube2402 may be attached to a mechanism that may hold bobbins of materialfor the supplemental mandrels that will be passed through the feed tube2402 to supplemental holes around the nose cone 2401.

In some embodiments, the feed tube 2402 may be attached to a drivemechanism that controls the rate of rotation of the feed tube 2402 andthus the rotation of the nose cone 2401. In some embodiments, the drivemechanism may be a rotating gear 2407. As the braider is braiding thebraid wires 2408 around the main process mandrel 2404, the drivemechanism is either geared to the braider itself or independentlycontrolled to vary or hold constant the rate of rotation of the rotatingfeed tube 2402 and thus the rate of rotation of the nose cone 2401. Therate of rotation and the rate of braiding will govern the pitch of thesupplemental mandrels on the main process mandrel 2404. As discussedearlier, this may affect the flexibility, stiffness, and “pushability”of the device.

In another embodiment, varying the circumferential orientation of thepull lumens may change the stiffness of the helixed section of theendoscope. In manufacture, this is achieved by altering the pitch of thesupplemental, spiraling mandrels. As the pitch (i.e., the angle off thelongitudinal axis) of the mandrels decreases, the bending stiffness ofthe braided composite increases. Conversely, as the pitch of thesupplemental mandrels increases, the bending stiffness decreases. Asshown in FIG. 10B, in some embodiments, the pitch of the supplementalmandrels may be varied within the helixed portion (1010). In thoseembodiments, the bending stiffness of the braided composite may varyeven within the helixed portion.

During the braiding process, the braiding machine may be stopped to makealterations to the braided composite. In some embodiments, onealteration may be the addition of straight wires or reinforcement rods.Reinforcement rods may significantly increase the buckling, axial andbending stiffness of a braided laminated composite. Reinforcement rodsmay be particularly helpful for longer endoscopes which may requirespecialized anti-buckling construction or manual assistance to reducethe buckling of the device so that it may be inserted into a patient. Insome embodiments, the braiding machine may be configured to selectivelybraid reinforcement rods that may be pulled from holes in the nose coneonto the process mandrel, where the reinforcement rods are captured andheld in place by the braid wire. The absence of reinforcement rods inthe distal region of the resulting endoscope preserves the device'sflexibility in the distal end while increasing the stiffness in theproximal region. This combination of properties makes the resultingendoscope easier for a physician to guide, insert, and push the deviceinto an endolumenal cavity of a patient.

Applying supplemental mandrels onto a main process mandrel using holesin a rotating nose cone provides a number of manufacturing advantages.By using holes in the nose cone, the mandrels are not pushed from thehorn gears. Pushing mandrels from the center of the individual horngears, which are also responsible for weaving the braid wire, results inthe mandrels being interwoven with the braid wire, which locks theresulting braid matrix in place longitudinally. This form ofconstruction, known as “zero degree construction,” limits the ability ofthe manufacturer to adjust the braid matrix for desirable flexibility orhoop strength. In zero degree construction, the supplemental mandrel isnecessarily confined in an “over-under manner” by the braid, resultingin all clockwise braided braid wire being woven “over” the supplementalmandrels, while all counter-clockwise braided braid wire is woven“under” the supplemental mandrels. As zero degree construction locks thesupplemental mandrels in place radially, it is undesirable where varyingthe pitch of the supplemental mandrel along the main process mandrel isrequired.

Additionally, use of the horn gears as a pass-through for thesupplemental mandrels limits the number of supplemental mandrels thatmay be applied to the main process mandrel. For example, a sixteencarrier braider can apply up to eight mandrels, a twenty-four carrierbraider can only have up to twelve mandrels. In contrast, use of holesin the nose cone allows any number of mandrels to be passed through tothe main process mandrel.

In some embodiments, the supplemental mandrels may be applied to themain process mandrel without the benefit of a second, outer layer ofbraid wire. Instead, the supplemental mandrels may be applied withoutbraid wire. In those embodiments, the bonded/fused polymer jacket mayhold the mandrels, and thus lumens in place. Alternatively, in someembodiments, the mandrels may be held in place using a casting aroundthe braided composite. Since the outer braid layer is absent from themanufacturing endoscopic device, the diameter and circumference of thedevice cross-section is reduced. Alternatively, the supplementalmandrels may be held in place by sleeving a polymer jacket over theprocess mandrel. In some embodiments, the casting is the same materialas the exterior material for the endoscopic device.

In some embodiments, the supplemental mandrels may be braided onto themain process mandrel much like the braid wire. For example, in someembodiments, the supplemental mandrels may be braided using the evennumbered horn gears, while held in place by braid wire braided using theodd numbered horn gears. In this way, the supplemental mandrels, andthus the lumens may be woven into the walls of the central lumen. As anadded benefit, embodiments manufactured using this means also tend tohave lower circumferential area.

Alternatively, in some embodiments, the helixed lumen structures may bemanufactured using extruded molds. These molds may generate the helixedlumen structures to create a jacket from PTFE, pebax, polyurethane, andnylon. In some embodiments, the extruded structures may be formed usinga mold around a braided mandrel.

In some embodiments, the helical lumen construction may be performed byrotating the main process mandrel as it is being drawn through thebraider. By rotating the main process mandrel, instead of the nose cone,the supplemental mandrels may be drawn through either a fixed nose coneor through the center of the horn gears during the braiding process. Inthis embodiment, the nose cone may be fixedly coupled to the nose coneholder and the main process mandrel is rotated as it drawn through thenose cone.

Construction of sheath 1000 from FIGS. 10A, 10B, and 10C and flexibleendoscope 1100 from FIGS. 11A and 11B are substantially the same. Thus,one of skill in the art would understand that the same principles applyto both tools.

In some embodiments, the helixed lumens may be positioned to beequidistant from each other. FIG. 25 illustrates a cross-sectional viewof a flexible endoscopic device where the pull lumens are arrangedsymmetrically around the circumference of the device, in accordance withan embodiment of the present invention. As shown in FIG. 25 , device2500 has a central working channel 2501, four pull lumens (2502, 2503,2504, and 2505) spaced symmetrically around the working channel 2501 andwithin the outer jacket 2506.

In some embodiments, though helixed, the lumens and pull wires may notbe distributed evenly or equidistant from each other around thecircumference of the sheath and/or flexible endoscope. In someapplications, grouping all of the lumens and pull wires onto the sameside or hemispheric region (e.g., top vs. bottom hemisphere) of thesheath and endoscope allows for a smaller outer diameter.

FIG. 26A illustrates a cross-sectional view of a flexible endoscopicdevice where the pull lumens are not arranged symmetrically around thecircumference of the device, in accordance with an embodiment of thepresent invention. Similar to device 2500 of FIG. 25 , device 2600 has aworking channel 2601, four pull lumens 2602, 2603, 2604, and 2605, andan outer jacket 2606. In some embodiments, the working channel may becreated by a hollow tube created from a flexible metal alloy, such asnitinol.

Rather than being arranged equidistant from each other, however, pulllumens 2602, 2603, 2604, and 2605 are grouped together to reduce theoutside diameter of the device, as shown by the circumference of theouter jacket 2606. Even though the pull lumens are not equidistant fromeach other around the circumference of the working channel 2601,helixing the pull lumens in the arrangement shown in device 2600 stillexhibits the advantages of helixing, e.g., avoiding muscling or curvealignment phenomena. Although the pull lumens of device 2600 arearranged adjacent to each other around working channel 2601, otherembodiments may be arranged in a different pattern such as spaced outwithin same hemisphere, clustered together, or another arrangement. Thejacket 2606 may be created from plastic or any other material that maybe stretched, bonded or melted during the manufacture of device 2600.

FIG. 26B illustrates an isometric view of the flexible endoscopic device2600 disclosed in FIG. 26A, in accordance with an embodiment of thepresent invention. As shown in the isometric view of FIG. 26B, pulllumens 2602, 2603, 2604, and 2605 helix around the working channel 2601.In some embodiments, the pitch of the helixed pull lumens may be variedin order to obtain desired properties, such as stiffness and bendingflexibility, from device 2600.

FIG. 27 illustrates a flow diagram for a method for manufacturing device2600, in accordance with an embodiment of the present invention. Asshown in step 2701, the manufacturing process 2700 begins with selectinga backbone for the workpiece. In some embodiments, the backbone may be ahollow tube, such as a hypodermic “hypo” tube or a nitinol tube. Aperson skilled in the art would recognize that tube materials may bepreferred since tubular structures simultaneously exhibit axialstiffness and low bending stiffness. Additionally, the tube provides fora working channel through which useful tools and cables may be inserted,such as optics, aspiration, irrigation, and controls. In someembodiments, the backbone may be a solid rod, such as for use as anarticulable guidewire.

Following the selection of a backbone, in step 2702, process mandrels(one or more) may then be spiraled around the backbone at the desiredpitch. In some embodiments, the process mandrels may be coated withpolytetrafluoroethylene (PTFE) for easy removal during step 2705. Thepitch of the spiraled mandrels may be fixed or dynamic, allowing for thedifferent bending and stiffness properties depending on the application.The lower the pitch, i.e., longitudinally parallel to the neutral axisof the backbone, the lower the axial compression under tension, whilealso exhibiting increased muscling and curve alignment phenomena. Higherpitch spiraling generally exhibits reduced muscling and curve alignmentphenomena at the cost of increased axial compression under tension.

In step 2703, the resulting workpiece, comprising of a backbone and atleast one spiraled mandrel, may then be sheathed or covered in a“jacket”. In some embodiments, the jacket is a simple extruded tube orsheath. Selection of the means of the sheathing may be critical; assheathing may inadvertently alter the pitch of the process mandrelsaround the backbone. In some embodiments, the “sheathing” process may beaccomplished by casting, deposition, overextrusion, or any other meansthat would be known in the art.

In step 2704, if not already bonded from the sheathing process, thejacket may be bonded to the workpiece. This may involve melting, moldingor bonding the to the workpiece using any number of processes known toone skilled in the art. Once bonded, the jacket may then hold theprocess mandrels in place.

In step 2705, once the bonding process is complete, the spiraled processmandrels may be removed to create helixed pull lumen cavities, i.e.,lumens, that run longitudinally along the length of the workpiece. Instep 2706, following removal of the mandrels, the pull wires may bethreaded into the remaining cavities. In operation, the pull wires maythen be used to facilitate pull wires for articulating the endoscopicdevice.

As method 2700 does not make use of braiding, it provides for theconstruction of workpieces and devices with relatively small outerdiameters, which may be appropriate for reaching areas requiring smallinstruments, e.g., microsurgical applications. While the method ofmanufacture previously discussed may be applied to devices of varyingsizes and outer diameters, the preferred embodiments generally have anouter diameter of less than 2 mm.

Integration of the resulting workpiece into an endoscopic device may beaccomplished by melting, molding, bonding, and casting the workpiecejacket to the outer jacket of other components, such as a flexure ortool tip. In some embodiments, the backbone may include structure for anadjoining microsurgical flexure tool, such as ribbing for an increasedbend radius and longitudinally-aligned cavities for tools and controlwires.

Endolumenal Navigation.

In an embodiment of the present invention, navigation of the roboticcatheter through anatomical lumens may involve use of computer-generatedthree-dimensional maps based on a collection of two-dimensional imagescreated by low dose computerized tomography (CT) scans. Two-dimensionalCT scans, each representing a cutaway view of the patient's internalanatomy, may be collected during pre-operative procedures. These scansmay be analyzed to determine cavities and anatomical spaces within thepatient, such as branches of a lung or the path of a urethra.

Having been analyzed to determine the relevant anatomical spaces withinthe patient, the spaces may be expressed as lumens with centerlinecoordinates, i.e., coordinates representing the center of the lumen, inthree-dimensional space. The volume of those cavities may be representedas a specific measurement of diameter distance at each centerlinecoordinate. By tracking the centerline and the corresponding diameterdistance measurements, a computer-generated model of a three-dimensionallumen may be generated. Grid coordinate data may thus be used to expressthree-dimensional spaces and cavities that represent the patient'sanatomy.

FIGS. 28A and 28B illustrates the relationship between centerlinecoordinates, diameter measurements and anatomical spaces. In FIG. 28A,anatomical lumen 2800 may be roughly tracked longitudinally bycenterline coordinates 2801, 2802, 2803, 2804, 2805, and 2806 where eachcenterline coordinate roughly approximates the center of the lumen. Byconnecting those coordinates, as shown by “centerline” 2807, the lumenmay be visualized. The volume of the lumen may be further visualized bymeasuring the diameter of the lumen at each centerline coordinate. Thus2808, 2809, 2810, 2811, 2812, and 2813 represent the measurements of thelumen 2800 at coordinates 2801, 2802, 2803, 2804, 2805, and 2806.

In FIG. 28B, lumen 2800 may be visualized in three-dimensional space byfirst locating the centerline coordinates 2801, 2802, 2803, 2804, 2805,and 2806 in three-dimensional space based on centerline 2807. At eachcenterline coordinate, the lumen diameter may be visualized as atwo-dimensional circular space with diameters 2808, 2809, 2810, 2811,2812, and 2813. By connecting those two-dimensional circular spaces inthree-dimensions, lumen 2800 may be approximated as three-dimensionalmodel 2814. More accurate approximations may be determined by increasingthe resolution of the centerline coordinates and measurements, i.e.,increasing the density of centerline coordinates and measurements for agiven lumen or subsection. Centerline coordinates may also includemarkers to indicate point of interest for the physician, includinglesions.

Having expressed, and subsequently generated, a three-dimensional modelof the anatomical space, a pre-operative software package may also beused to analyze and derive an optimal navigation path based on thegenerated module. For example, the software package may derive shortestpath to a single lesion (marked by a centerline coordinate) or severallesions. This path may be presented to the operator intra-operativelyeither in two-dimensions or three-dimensions depending on the operator'spreference.

FIG. 29 illustrates a computer-generated three-dimensional modelrepresenting an anatomical space, in accordance with an embodiment ofthe invention. As discussed earlier, model 2900 may be generated usingcenterline 2901 that was obtained by reviewing CT scans that wereperformed preoperatively. In some embodiments, computer software may beable to map the optimum path 2902 for the catheter system to access anoperative site 2903 within model 2900, and thus the correspondinganatomical space. In some embodiments, the operative site 2903 may belinked to an individual centerline coordinate 2904, which allows acomputer algorithm to topologically search the centerlines of model 2900for the optimum path 2902 for the catheter system.

Tracking the distal end of the robotic catheter within the patient'sanatomy, and mapping that location to placement within a computer model,enhances the navigational capabilities of the catheter system. In orderto track the distal working end of the robotic catheter, i.e.,“localization” of the working end, a number of approaches may beemployed, either individually or in combination.

In a sensor-based approach to localization, a sensor, such as anelectromagnetic (EM) tracker, may be coupled to the distal working endof the robotic catheter to provide a real-time indication theprogression of the robotic catheter. In EM-based tracking, an EMtracker, embedded in the robotic catheter, measures the variation in theelectromagnetic field created by one or more static EM transmitters. Thetransmitters (or field generators), may be placed close to the patientto creates a low intensity magnetic field. This induces small-currentsin sensor coils in the EM tracker, which are correlated to the distanceand angle between the sensor and the generator. The electrical signalmay then be digitized by an interface unit (on-chip or PCB) and sent viacables/wiring back to the system cart and then to the command module.The data may then be processed to interpret the current data andcalculate the precise location and orientation of the sensor relative tothe transmitters. Multiple sensors may be used at different locations inthe catheter, for instance in leader and sheath in order to calculatethe individual positions of those components. Thus, based on readingsfrom an artificially-generated EM field, the EM tracker may detectchanges in field strength as it moves through the patient's anatomy.

FIG. 30 illustrates a robotic catheter system that makes use of anelectromagnetic tracker in combination with an electromagnetic fieldgenerator, in accordance with an embodiment in the present invention. Asrobotic system 3000 drives a robotically driven catheter 3001 into thepatient 3002, an electromagnetic (EM) tracker 3003 at the distal end ofthe robotic catheter 3001 may detect an EM field generated by EM fieldgenerator 3004. The EM readings of the EM tracker 3003 may betransmitted down the shaft of the robotic catheter 3001 to the systemcart 3005 and to command module 3006 (which contains relevant softwaremodules, a central processing unit, a data bus and memory) forinterpretation and analysis. Using the readings from EM tracker 3003,display modules 3007 may display the EM tracker's relative positionwithin a pre-generated three-dimensional model for review by theoperator 3008. The embodiments also provide for the use of other typesof sensors, such as fiber optic shape sensors. While a variety ofsensors may be used for tracking, the choice of sensor may be inherentlylimited based on (i) the size of the sensor within the robotic catheterand (ii) the cost of manufacturing and integration the sensor into therobotic catheter.

Prior to tracking a sensor through the patient's anatomy, the trackingsystem may require a process known as “registration,” where the systemfinds the geometric transformation that aligns a single object betweendifferent coordinate systems. For instance, a specific anatomical siteon a patient has two different representations in the CT modelcoordinates and in the EM sensor coordinates. To be able to establishconsistency and common language between these coordinate systems, thesystem needs to find the transformation that links these tworepresentations, i.e., registration. In other words, the position of theEM tracker relative to the position of the EM field generator may bemapped to a three-dimensional coordinate system to isolate a location ina corresponding three-dimensional model.

In some embodiments, registration may be performed in several steps.FIG. 31 illustrates a flow diagram for a registration process, inaccordance with an embodiment of the present invention. To start, instep 3101, the operator must first position the working end of therobotic catheter at a known starting location. This may involve usingvideo imagery data from the catheter camera to confirm the startinglocation. Initial positioning may be accomplished by identifyinganatomical features through a camera located at the working end of thecatheter. For example, in bronchoscopy, registration may be performed bylocating the base of the trachea, distinguished by locating the two mainbronchial tubes for the left and right lung. This location may beascertained using video images received by the camera in the distal endof the catheter. In some embodiments, the video data may be compared todifferent cross sectional views of a pre-generated computer model of thepatient's anatomy. By sorting through cross-sectional views, the systemmay identify the location associated with the cross-section with thesmallest amount of differences, or “errors,” to find the “match.”

In step 3102, the operator may “drive” or “extend” the robotic catheterinto unique anatomical spaces that have already been mapped. Forexample, in bronchoscopy, the operator may drive the catheter downunique bronchial paths from the base of the trachea. Because the base ofthe trachea splits into two bronchial tubes, an operator may drive therobotic catheter into one tube and track the working end of the roboticcatheter using an EM tracker.

In step 3103, the operator monitors the relative travel of the roboticcatheter. Monitoring of the robotic catheter may make use of either theEM tracker or fluoroscopy to determine relative movement of the roboticcatheter. Evaluation of the relative displacement of the working end ofthe robotic catheter may be compared the computer model generated frompre-operative CT scan data. In some embodiments, the relative movementmay be matched with centerlines in the computer model, where thetransformation matrix leads to the least error is the correctregistration. In some embodiments, the system and operator may trackinsertion data (discussed below) and orientation data from anaccelerometer and/or gyroscope (discussed below).

In step 3104, the operator may decide to drive into more anatomicalspaces (3102) and collect more locational information (3103) prior tocomparing and analyzing the positional data. For example, inbronchoscopy, the operator retract the catheter from one bronchial tubeback the tracheal tube and drive the catheter into another bronchialtube in order to collect more positional data. Once the operator issatisfied, the operator may stop driving (3102) and monitoringpositional data (3103) and proceed to process the data.

In step 3105, the system may analyze the collected positional data andcompare the data to pre-generated computer models to register thedisplacement of the catheter within patient's anatomy to the model.Therefore, by comparing the movement in the patient's anatomy to thethree-dimensional model of the patient's anatomy, the system may be ableto register the tracker relative to both spaces—three-dimensionalcomputer model vs. patient anatomical space. After analysis, theregistration process may be complete (3106).

In some cases, it may be necessary to perform a “roll registration” inorder to confirm the orientation of the robotic catheter. This may beparticularly important in step 3101 prior to driving into un-registeredanatomical spaces. In bronchoscopy, proper vertical orientation ensuresthat the operator may distinguish between the right and left bronchi.For example within the base of the trachea, images of the left and rightbronchi may appear very similar regardless of whether the camera isoriented at zero degrees or one-hundred eighty degrees. Rollregistration may also be important because the kinematics of the roboticcatheter typically results in a slight rotation during tortuousnavigation within a patient.

Roll registration may be important at the operative site when theworking channel may be occupied by the sensor. For example, inembodiments with only a single working channel, upon reaching theoperative site, the physician may need to remove the EM tracker from therobotic catheter in order to make use of another tool, such as a grasperor forceps. Upon removal, however, the system may lose its localizationcapabilities without the EM tracker. Thus, when ready to leave theoperative region, insertion of the EM tracker may require that the rollregistration be again performed to ensure proper orientation.

In some embodiments, the rotation of the robotic catheter may be trackedusing an accelerometer mounted within the distal working end of thedevice. Use of an accelerometer to detect gravitational forces on thecatheter provides information regarding the location of the roboticcatheter relative to the ground. The location of the ground relative tothe catheter may be used to solve certain ambiguities. In bronchoscopy,for example, knowing the orientation (0 or 180 degrees) of the distalcamera of the catheter would help determine the appropriate bronchialbranch at the start. During navigation, data from the accelerometer totrack the direction of gravity, and thus orientation, may also be usedto auto-correct the camera image displayed on the control console,ensuring that the displayed image is always oriented vertically.

In a preferred embodiment, a 3-axis MEMS-based sensor chip with anaccelerometer may be coupled near the tip of the catheter, on the sameprinted circuit board as the digital camera. The accelerometer measuresthe linear acceleration along the three different axes to calculate thevelocity and direction of the catheter tip. It accelerometer alsomeasures the direction of gravity and thus provides absolute informationabout the orientation of the catheter. The accelerometer readings re betransmitted using digital or analog signals through a communicationprotocol like I2C. The signal may be transmitted through wiring to theproximal end of the catheter and from there to the system cart andcommand module for processing.

In a three-axis sensor, the accelerometer may be able to determinelocation of the ground relative to the catheter. If the catheter doesnot roll or bend up to ninety degrees, a two axis accelerometer could bealso be useful. Alternatively, a one-axis sensor may be useful if theaxis of the accelerometer remains perpendicular to the direction ofgravity, i.e., perpendicular to the ground. Alternatively, a gyroscopemay be used to measure the rate of rotation, which may then be used tocalculate the articulation of the catheter.

Some embodiments make use of an EM tracker in combination with theaccelerometer to supplement any orientation readings from theaccelerometer. In some embodiments, use of fluoroscopy to track therobotic catheter may also supplement the registration process. As knownin the art, fluoroscopy is an imaging technique that uses X-rays toobtain real-time moving images of the internal structures of a patientthrough the use of a fluoroscope. Two-dimensional scans generated byfluoroscopy may assist with localization in certain situations, e.g.,identifying the relevant bronchi.

Tracking using fluoroscopy may be performed using a plurality ofradio-opaque markers on the catheter. Many features of the catheter arenaturally radio-opaque to x-rays, including the camera head, the controlring and pull wires; thus, the marker location together with themetallic components of the catheter may be used to obtain athree-dimensional transformation matrix. Once registration has happened,visual images detecting branch locations may be precisely correlated tothe three-dimensional model. In addition, the full branch length andbranch location in 3D can be measured and enhanced in the map.

In contrast to a sensor-based approach, vision-based tracking involvesusing images generated by a distally-mounted camera to determine thelocation of the robotic catheter. For example, in bronchoscopy, featuretracking algorithms may be used to identify circular geometriescorresponding to bronchial paths and track the change of thosegeometries from image to image. By tracking the direction of thosefeatures as they move from image to image, the system may be able todetermine which branch was selected, as well as the relative rotationaland translational motion of the camera. Use of a topological map of thebronchial paths may further enhance vision-based algorithms.

In addition to feature based tracking, image processing techniques suchas optical flow may also be used to identify branches in the airwaytopology in bronchoscopy. Optical flow is the displacement of imagepixels from one image to the next in a video sequence. With respect tobronchoscopy, optical flow may be used to estimate the movement of thetip of the scope based on changes in the camera images received at thetip of the scope. Specifically, in a series of video frames, each framemay be analyzed to detect translation of the pixels from one frame tothe next. For example, if the pixels in a given frame appear totranslate to the left in the next frame, the algorithm would infer thatthe camera, and in turn the tip of the scope, moved to the right.Through comparing many frames over many iterations, movement (and thuslocation) of the scope may be determined.

Where stereoscopic image capture—as opposed to monocular imagecapture—is available, optical flow techniques may also be used tocomplement the pre-existing three-dimensional model of the anatomicregion. Using stereoscopic image capture, the depth of the pixels in thetwo-dimensional captured images may be determined to build athree-dimensional map of objects in the camera view. Extrapolating totravel within an anatomical lumen, this technique enables the system todevelop three-dimensional maps of the local surroundings around thecatheter while navigating in inside the patient's anatomy. These mapsmay be used to extend the pre-determined three-dimensional computermodels where the models either are missing data or of low quality. Inaddition to a stereoscopic camera apparatus, depth sensors or specificlighting configurations and image capture techniques—such as RGB-Dsensors or structure lighting—may need to be used.

Regardless of tracking method—either sensor-based orvision-based—tracking may be improved by using data from the roboticcatheter itself. For example, in robotic catheter 200 from FIG. 2A, therelative insertion length of sheath 201 and leader 205 may be measuredfrom a known, starting position within the trachea (in the case ofbronchoscopy). Using relative insertion length and the centerlines of athree-dimensional model of the patient's bronchial tree, the system maygiving a rough estimation of the location of the working end afterdetermining whether the robotic catheter is located in a branch and thedistance traveled down that branch. Other control information from therobotic catheter may also be used, such as catheter device articulation,roll, or pitch and yaw.

Real-time imaging based on different imaging modalities would furtherenhance navigation, particularly at the operative site. Even thoughtracking may assist with rough navigation to the operative site,additional modalities may be useful when more precise handling isnecessary, such when attempting to biopsy a lesion. Imaging tools suchas fluorescence imaging, near infrared imaging, oxygen sensors,molecular biomarker images, and contrast dye imaging may help pinpointthe exact coordinates of the lesion in the computer model, and thusassist with operating a biopsy needle at the operative site. In theabsence of a precise location, the robotic catheter may be used tobiopsy the entire region of the operative site at a known depth, thusensuring tissue from the lesion is sampled.

In some cases, the segmented CT scans, and thus the resulting computermodels, do not show branches at the periphery of the lung (in thecontext of bronchoscopy). This may be due to insufficient inflation ofthe airways during a scan, or because the size of the branches is belowthe resolution of a CT scan (typically on the order of 1 millimeter). Inpractice, the robotic system may enhance the computer model during theprocedure by noting the location and the position and orientation of theunmapped branch. In some embodiments, the topology structure may allowphysicians to mark their location and return to that same location inorder to examine the periphery branches. In some embodiments, thecatheter camera may measure the diameter and shape of the branches basedon the capture images, allowing those branches to be mapped based onposition and orientation.

Endolumenal Procedures.

FIG. 32A illustrates the distal end of a robotic catheter within ananatomical lumen, in accordance with an embodiment of the presentinvention. In FIG. 32A, robotic catheter 3200, comprising a shaft 3201is shown navigating through an anatomical lumen 3202 towards anoperative site 3203. During navigation, the shaft 3201 may beunarticulated.

FIG. 32B illustrates the robotic catheter from FIG. 32A in use at anoperative site within an anatomical lumen. Having reached the operativesite 3203, a distal leader section 3204, longitudinally aligned with theshaft 3201, may be extended from shaft 3201 in the direction marked byarrow 3205. Distal leader section 3204 may also be articulated in orderto direct tools towards operative site 3203.

FIG. 32C illustrates the robotic catheter from FIG. 32B in use at anoperative site within an anatomical lumen. In cases where the operativesite contains a lesion for biopsy, the distal leader section 3204 mayarticulate in the direction marked by arrow 3206 to convey an aspirationneedle 3207 to target a lesion at operative site 3203. In someembodiments, distal leader section 3204 may be articulated to directbiopsy forceps to remove samples of anatomical tissues for purposes ofintraoperative evaluation. For purposes of activation of that endeffector, robotic catheter 3200 may comprise a tendon operativelycoupled to the biopsy forceps.

FIG. 33A illustrates a robotic catheter coupled to a distal flexuresection within an anatomical lumen, in accordance with an embodiment ofthe present invention. In FIG. 33A, a robotic catheter 3300, comprisinga shaft 3301, flexure section 3302, and forceps 3303, is shownnavigating through an anatomical lumen 3304 towards an operative site.During navigation, both the shaft 3301 and distal flexure section 3302may be unarticulated as shown in FIG. 33A. In some embodiments, theflexure section 3302 may be retracted within shaft 3301. Theconstruction, composition, capabilities, and use of flexure section 3302is disclosed in U.S. patent application Ser. No. 14/201,610, filed Mar.7, 2014, and U.S. patent application Ser. No. 14/479,095, filed Sep. 5,2014, the entire contents of which are incorporated by reference.

In some embodiments, the flexure 3302 may be longitudinally-aligned withthe shaft 3301. In some embodiments, the flexure 3302 may be deployedthrough a working channel that is off-axis (neutral axis) of shaft 3301,allowing for the flexure 3302 to operate without obscuring a cameralocated at the distal end of shaft 3301. This arrangement allows anoperator to use a camera to articulate flexure 3302 while shaft 3301remains stationary.

Similar to other embodiments, different tools, such as forceps 3303, maybe deployed through the working channel in flexure section 3302 for useat the distal end of the flexure section 3302. In other scenarios,surgical tools such as graspers, scalpels, needles, and probes may belocated at the distal end of the flexure section 3302. In roboticcatheter 3300, as in other embodiments, the tool at the distal end ofthe bending section may be substituted intra-operatively in order toperform multiple treatments in a single procedure.

FIG. 33B illustrates a robotic catheter from FIG. 33A with a forcepstool in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention. Navigation ofrobotic catheter 3300 through anatomical lumen 3304 may be guided by anynumber of the various navigational technologies discussed above. Oncethe robotic catheter 3300 has reached its desired location at theoperative site 3306, flexure section 3302 may articulate in thedirection of arrow 3305 in order to orient forceps 3303 towardsoperative site 3306. Using forceps 3303, robotic catheter 3300 may takea biopsy of the tissue at the operative site 3306.

FIG. 33C illustrates a robotic catheter from FIG. 33A with a laserdevice in use at an operative site within an anatomical lumen, inaccordance with an embodiment of the present invention. Having reachedthe operative site 3306, the flexure section 3302 of robotic catheter3300 may be articulated and a laser tool 3307 may be deployed throughthe working channel of the shaft 3301 and flexure section 3302. Oncedeployed, the laser tool 3307 may be directed to operative site 3306 toemit laser radiation 3308 for purposes of tissue ablation, drilling,cutting, piercing, debriding, cutting or accessing non-superficialtissue.

Command Console.

As discussed with respect to system 100 from FIG. 1 , an embodiment ofthe command console allows an operator, i.e., physician, to remotelycontrol the robotic catheter system from an ergonomic position. In thepreferred embodiment, the command console utilizes a user interface thatboth (i) enables the operator to control the robotic catheter, and (ii)displays the navigational environment from an ergonomic position.

FIG. 34 illustrates a command console for a robotic catheter system, inaccordance with an embodiment of the present invention. As shown in FIG.34 , command console 3400 may comprise a base 3401, display modules,such as monitors 3402, and control modules, such as keyboard 3403 andjoystick 3404. In some embodiments, the command module functionality maybe integrated into the system cart with the mechanical arms, such assystem cart 101 from system 100 in FIG. 1 .

The base 3401 may comprise of a central processing unit, a memory unit,a data bus, and associated data communication ports that are responsiblefor interpreting and processing signals, such as camera imagery andtracking sensor data, from the robotic catheter. In other embodiments,the burden of interpretation and processing signals may be distributedbetween the associated system cart and the command console 3400. Thebase 3401 may also be responsible for interpreting and processingcommands and instructions from the operator 3405 through the controlmodules, such as 3403 and 3404.

The control modules are responsible for capturing the commands of theoperator 3405. In addition to the keyboard 3403 and joystick 3404 inFIG. 34 , the control modules may comprise other control mechanismsknown in the art, including but not limited to computer mice, trackpads,trackballs, control pads, and video game controllers. In someembodiments, hand gestures and finger gestures may also be captured todeliver control signals to the system.

In some embodiments, there may be a variety of control means. Forexample, control over the robotic catheter may be performed in either a“Velocity mode” or “Position control mode”. “Velocity mode” consists ofdirectly controlling pitch and yaw behaviors of the distal end of therobotic catheter based on direct manual control, such as throughjoystick 3404. For example, right and left motions on joystick 3404 maybe mapped to yaw and pitch movement in the distal end of the roboticcatheter. Haptic feedback in the joystick may also be used to enhancecontrol in “velocity mode”. For example, vibration may be sent back tothe joystick 3404 to communicate that the robotic catheter cannotfurther articulate or roll in a certain direction. Alternatively, pop-upmessages and/or audio feedback (e.g., beeping) may also be used tocommunicate that the robotic catheter has reached maximum articulationor roll.

“Position control mode” consists of identifying a location in athree-dimensional map of the patient and relying on the system torobotically steer the catheter the identified location based onpre-determined computer models. Due to its reliance on athree-dimensional mapping of the patient, position control mode requiresaccurate mapping of the patient's anatomy.

Without using the command module 3401, the system may also be directlymanipulated by manual operators. For example, during system setup,physicians and assistants may move the mechanical arms and roboticcatheters to arrange the equipment around the patient and the operatingroom. During direct manipulation, the system may rely on force feedbackand inertia control from human operators to determine the appropriateequipment orientation.

The display modules 3402 may comprise monitors, virtual reality viewingdevices, such as goggles or glasses, or other means of display visualinformation regarding the system and from the camera in the roboticcatheter (if any). In some embodiments, the control modules and displaymodules may be combined, such as in a touchscreen in a tablet orcomputer device. In a combined module, the operator 3405 may be able toview visual data as well as input commands to the robotic system.

In another embodiment, display modules may display three-dimensionalimages using a stereoscopic device, such as a visor or gogglearrangement. Using three-dimensional images, the operator may view an“endo view” of the computer model, a virtual environment of the interiorof the three-dimensional computer-generated model of the patient'sanatomy to approximate the expected location of the device within thepatient. By comparing the “endo view” to the actual camera images, thephysician may be able to mentally orient himself and confirm that therobotic catheter is in the right location within the patient. This maygive the operator a better sense of the anatomical structures around thedistal end of the robotic catheter.

In a preferred embodiment, the display modules 3402 may simultaneouslydisplay the pre-generated three-dimensional models, the pre-determinedoptimal navigation paths through the models, and CT scans of the anatomyat the current location of the distal end of the robotic catheter. Insome embodiments, a model of the robotic catheter may be displayed withthe three-dimensional model of the patient's anatomy, to further clarifythe status of the procedure. For example, a lesion may have beenidentified in a CT scan where a biopsy may be necessary.

During operation, camera means and illumination means at the distal endof the robotic catheter may generate a reference image in the displaymodules for the operator. Thus, directions in the joystick 3404 causingarticulation and rolling of the distal end of the robotic catheterresults in an image of the anatomical features directly in front of thedistal end. Pointing the joystick 3404 up may raise the pitch of thedistal end of the robotic catheter with the camera, while pointing thejoystick 3404 down may decrease the pitch.

The display modules 3402 may automatically display different views ofthe robotic catheter depending on the operators' settings and theparticular procedure. For example, if desired, an overhead fluoroscopicview of the catheter may be displayed during the final navigation stepas it approached the operative region.

Virtual Rail for Vascular Procedures.

FIG. 35A illustrates an isometric view of a robotic catheter system, inaccordance with an embodiment of the present invention. As shown in FIG.35A, the system 3500 delivers catheter device 3501 use of threemechanical arms (3502, 3503, and 3504) that are operatively coupled tothe operating table 3505. Aligning the mechanical arms at angle relativeto an insertion point 3507 in the femoral artery, the mechanical arms3502, 3503, and 3504, the system 3500 may configure the catheter device3501 into a virtual rail to access the femoral artery and the rest ofthe vascular system of the patient 3506. From within the femoral artery,the flexible catheter device may be articulated and “driven” throughoutthe rest of the patient's vascular system, such as up to the patient'sheart.

FIG. 35B illustrates a top view of robotic catheter system 3500, inaccordance with an embodiment of the present invention. As shown in FIG.35A, the mechanical arms 3502, 3503, and 3504 may be used to create avirtual rail for the catheter device 3501 above the left leg of thepatient 3506. Hence, the flexibility of the mechanical arm system makespossible access to the insertion point 3507.

FIG. 36 illustrates an isometric view of a robotic catheter system wherethe angle of the virtual rail is greatly increased, in accordance withan embodiment of the present invention. Given its use of mechanicalarms, the present invention allows for greater angles of insertion,depending on the application, procedure, and desires of the operator. Asshown in FIG. 36 , system 3600 may comprise three mechanical arms 3602,3603, and 3604 operatively coupled to an operating bed 3605 with apatient 3606. The catheter 3601 may be aligned in a virtual rail intothe patient's femoral artery within the patient's right leg 3607. Inthis arrangement, the angle between the device 3601 and the patient'sleg 3607 may exceed forty-five degrees.

With the aid of the robotic control, the angle may also be changedintraoperatively, such that the insertion trajectory may differ from thestart to the finish. Altering the insertion trajectory intraoperativelymay allow for more flexible operating room arrangements. For example, itmay be advantageous for a low initial insertion angle. However, as theprocedure progresses it may be more convenient for the operator toincrease the angle to provide additional clearance between the patientand the robotic system.

In addition to multiple rail configurations, the system's use ofmechanical arms provides additional benefits. In current flexiblecatheter technologies, the flexible catheter often experiencesresistance upon insertion of the catheter. This resistance, combinedwith the bendability of the catheter, results in the undesirable bendingof the catheter exterior to the patient, i.e., “buckling” duringinsertion from “pushing” the catheter into the patient's body. This“buckling” phenomenon may be typically resolved by manually threadingthe catheter into the insertion point, resulting in additional labor forthe operator. Moreover, the unsupported external portion of the catheterresulting from the “buckling” phenomenon is undesirable. The torquesensing algorithms and mechanisms may be used to identify instances ofbuckling in addition to external force inputs, as such force measurementmay have a unique signature.

FIGS. 37A-37D illustrates a series of top views of a vascular procedurewhere the use of mechanical arms reduces catheter buckling and wastedlength, in accordance with an embodiment of the present invention. InFIG. 37A, system 3700 incorporates the use of four mechanical arms 3702,3703, 3704, and 3705 operatively coupled to an operating bed 3706 with apatient 3707. As shown in FIG. 37A, the arms may be used to align acatheter device 3701 into a virtual rail with an insertion point 3708 inthe femoral artery in the right leg of the patient 3707.

The different arms in system 3700 serve different purposes formaneuvering the catheter 3701. Arms 3702 and 3703 may drive the catheterdevice 3701 through driving the tool bases 3709 and 3710 of catheter3701. Tool bases 3709 and 3710 may be “driven” using any number ofmeans, including direct drive methods discussed infra. Mechanisms at theflange points of arms 3704 and 3705 may be used to support catheterdevice 3701 to reduce buckling and reduce wasted length. The flangepoints 3711 and 3712 may support catheter 3707 through either passive ordirect drive means. In passive support, the flange points 3711 and 3712may use a simple loop, groove, redirect surface, or a passive rotarysurface (i.e., wheels or rollers). In the embodiment shown in FIG. 37A,the flange points 3711 and 3712 provide passive “anti-buckling” supportto catheter 3701. In passive support, arms 3704 and 3705 may move alongthe virtual to support the catheter device 3701 where it is mostlylikely to bend. For example, in some embodiment, the arms 3704 and 3705are configured to always maintain equal distances from the patient'sbody and the tool bases.

FIG. 37B illustrates a top view of the vascular procedure from FIG. 37Ausing system 3700, in accordance with an embodiment of the presentinvention. As shown in FIG. 37B, as the catheter 3701 is furtherinserted into the femoral artery of patient 3707, the support arm 3705may be retracted to provide clearance for inserting the catheter 3701into the patient. Thus, the arm 3705 may provide “anti-buckling” supportwhen the catheter 3701 is first inserted, and may be removed whenextension of the catheter 3701 is needed. This flexibility providesimproved control over the catheter 3701 and reduces “wasted length”along the catheter 3701.

FIG. 37C illustrates a further top view of the vascular procedure fromFIG. 37B using system 3700, in accordance with an embodiment of thepresent invention. As shown in FIG. 37C, as the catheter 3701 is againfurther inserted into the patient's femoral artery through insertionpoint 3708, support arm 3704 may also be retracted to provide clearancefor inserting the catheter 3701 into the patient 3707. As with supportarm 3705, the arm 3705 may provide “anti-buckling” support when needed,and may be retracted when further extending the catheter 3701.

In active support, the flange points on mechanical arms 3704 and 3705may be a motorized or mechanized drive system, such as graspers oractive rotary surfaces (i.e., wheels or rollers). In some embodiment,the flange points may remain stationary, as opposed to always adjustingin the case of passive support.

FIG. 37D illustrates a top view of a vascular procedure where mechanicalarms provide active drive support through the use of motorized rollersat the flange points of the arms, in accordance with an embodiment ofthe present invention. Specifically, FIG. 37D illustrates the use ofsystem 3700 from FIGS. 37A-37C where the passive support systems atflange points 3711 and 3712 are replaced by active drive mechanisms,such as rollers 3713 and 3714. In FIG. 37D, the active drive mechanisms3713 and 3714 provide mechanized support to prevent anti-buckling. Insome embodiments, the angular speed of the rollers may be synchronizedwith the drive controls over tool bases 3709 and 3710 to ensure properinsertion speed and control. Additionally, in order to replicate thepushing motion of a physician, active drive mechanisms 3713 and 3714 arelocated as close as possible to the insertion point. As the catheter3701 is extended into the patient, the arms 3703 and 3704 may beretracted as necessary to get maximum extension length out of thecatheter 3701.

While embodiments have been discussed with respect to access to thefemoral artery, very similar arrangements of the mechanical arms may beconfigured in order to gain access to the femoral vein and saphenousvein.

The flexibility of the present invention allows for a variety vascularprocedures that require access to different points in the patient'svascular system. FIGS. 38A and 38B illustrate a vascular procedure wherea robotic catheter may be inserted into the carotid artery, inaccordance with an embodiment of the present invention. Specifically,FIG. 38A illustrates an isometric view of a vascular procedure where acatheter may be inserted into the carotid artery. As shown in FIG. 38A,the system 3800 delivers catheter 3801 using two mechanical arms (3802and 3803) that are operatively coupled to the operating table 3804. Themechanical arms 3801 and 3802 may align the catheter 3801 into a virtualrail to access insertion point 3805 in the carotid artery and the restof the vascular system of the patient 3806.

FIG. 38B illustrates a top view of vascular system 3800, in accordancewith an embodiment of the present invention. As shown in FIG. 38B, themechanical arms 3802 and 3803 may be used to create a virtual rail forthe catheter 3801 above the shoulder of the patient 3806. Hence, theflexibility of mechanical arms 3802 and 3803 makes possible access toinsertion point 3805 at the carotid artery.

FIG. 39 illustrates a vascular procedure where a robotic catheter may beinserted into the brachial artery, in accordance with an embodiment ofthe present invention. In FIG. 39 , the system 3900 delivers catheter3901 using two mechanical arms (3902 and 3903) that are operativelycoupled to the operating table 3904. In order to accommodate access tothe insertion point 3905, operating table 3904 may be outfitted with aleft extension 3906 and a right extension 3907, both of which includerails to allow arms 3902 and 3903 to slidingly access the extensions.Mechanical arms 3902 and 3903 may then align the catheter 3901 into avirtual rail to access the insertion point 3905 in the brachial arteryand the rest of the vascular system of the patient 3908.

FIGS. 40A and 40B illustrate a vascular procedure where a roboticcatheter may be inserted into the radial artery, in accordance with anembodiment of the present invention. Specifically, FIG. 40A illustratesan isometric view of a vascular procedure where a catheter may beinserted into the radial artery. As shown in FIG. 40A, the system 4000delivers catheter 4001 using two mechanical arms (4002 and 4003) thatare operatively coupled to the operating table 4004. The mechanical arms4002 and 4003 may align the catheter 4001 into a virtual rail to accessinsertion point 4005 in the radial artery and the rest of the vascularsystem of the patient 4006.

FIG. 40B illustrates a top view of vascular system 4000, in accordancewith an embodiment of the present invention. As shown in FIG. 40B, themechanical arms 4002 and 4003 may be used to create a virtual rail forthe catheter 4001 above the wrist of the patient 4006. Hence, theflexibility of mechanical arms 4002 and 4003 makes possible access toinsertion point 4005 at the radial artery.

Thus, a plurality of arms and/or platforms may be utilized to form a“virtual rail” to enable a variety of procedures that require a varietyof patient access points. In operation, each platform/arm must beregistered to the others, which can be achieved by a plurality ofmodalities including, vision, laser, mechanical, magnetic, or rigidattachment. In one embodiment, registration may be achieved by amulti-armed device with a single base using mechanical registration. Inmechanical registration, an embodiment may register arm/platformplacement, position, and orientation based on their position,orientation and placement relative to the single base. In anotherembodiment, registration may be achieved by a cart-based system withmultiple base using individual base registration and “hand-shaking”between multiple robot arms. In cart-based embodiments with multiplebases, registration may be achieved by touching together arms fromdifferent bases, and calculating locations, orientation and placementbased on (i) the physical contact and (ii) the relative locations ofthose bases. Registration techniques in bed- or table-based systems maybe different. In some embodiments, registration targets may be used tomatch the position and orientations of the arms relative to each other.Through such registration, the arms and instrument driving mechanismsmay be calculated in space relative to each other.

Methods for Virtual Rail Alignment.

FIG. 41 shows a flow chart illustrating a method 4100 for aligning thearms of a robotic surgery system. The arms of the robotic surgery systemmay be aligned according to the method 4100 before, during, or after anoperation on a patient. In some embodiments, arm alignment methods mayincorporate the use of an offset for accommodating configurations thatare involve curved paths or jointed paths (such as Y-shapes).

In a step 4110, the first and second robotic arms of the system may beregistered with one another. In some embodiments, the system maycomprise a third robotic arm or further robotic arm(s) which may beregistered with one another.

In a step 4120, the first and second robotic arms, typically their toolbases, may be aligned to be in a virtual rail configuration. Typically,the end effectors, interface ends, device manipulators, or tool bases ofthe robotic arms may be robotically aligned in the virtual rail. In someembodiments, a third robotic arm or further robotic arm(s) may bealigned to be in the virtual rail configuration as well. In someembodiments, a third robotic arm may be used to position a patientinterface device at the patient access point. In some embodiments, athird robotic arm may be used to position a guidewire or toolmanipulator for use in the working channel of an endoscopic device.

In a step 4130, an admittance/impedance mode of the robotic surgerysystem may be enabled. The admittance/impedance mode may be enabled inany number of ways such as with voice control, joystick control, pedalcontrol, computer device control, etc. Admittance mode for a roboticcomponent is generally a control algorithm in which the robot translatesa sensed force to a velocity or acceleration command. Torque sensors ortactile sensors on the robot arm sense an external force, such as aperson pushing on the end of the arm, and use the force vector as acommand to the robot to move. However, unintended external forces, suchas an accidental bump, may cause the robot to move if admittance mode isenabled. The use of buttons or toggle switches can enable/disableadmittance mode, but can become difficult for a person to interact withmultiple arms.

In some embodiments, the use of direct physical input to the arms, suchas a “tap” or “push on the arms can also be used to enable admittancemode. This may simplify human-to-robot interaction and make it moreinstinctive. For example, in an embodiment, when admittance mode isdisabled the robot holds position while the torque sensors continuouslyread—and wait for—inputs. When a double tap is performed on the arm, thetap signature is identified by an algorithm and switches the robot toadmittance mode.

Put differently, admittance control is an approach to the control ofdynamic interaction from a robot to its environment. In admittancecontrol, the robot takes force as an input and calculates a resultingvelocity or acceleration as its output. If a robot in admittance mode isgiven an external force, such as a push, the controller will drive therobot to move in the opposite direction until the force is minimized.Virtual parameters such as mass, spring, and damping can be tuned inadmittance control to change the relationship between force andposition.

In contrast, impedance mode is the inverse of admittance mode. Inimpedance mode, the robotic component has a position input which resultsin a force output. The control loop uses a position measurement todetermine whether to output an external force. For example, a robot inimpedance mode may be directed to move forward (input) until it touchesa wall and to touch the wall at a constant force of 5 Newtons (force).When a robot in impedance mode is given a force profile to follow, therobot will move to maintain that force profile. In layman's terms, therobotic component moves away to avoid an applied external force inadmittance mode, while the robotic component moves to maintain anapplied external force in impedance mode.

In a step 4140, the first robotic arm may detect a user exerted force onthe first robotic arm. The first robotic arm may comprise one or morelinks and joints; and, the first robotic arm may comprise a torquesensor coupled to the joint or a tactile and/or force sensor coupled tothe link, such as by being placed over the outer surface of the link.For example, the robotic arm may comprise a series of actuators held bylinks in-between and may comprise a 7 actuator, serial chain arm; and,the robotic arm may sense torque at each joint and/or have tactilesensing along the robotic arm. Alternatively or in combination, a forcesensor may also be coupled to the tool base, device manipulator, orinterface end of the first robotic arm. The second or further roboticarm (s) may be similar to the first robotic arm.

The robotic arm may be coupled to a controller implementing an algorithmto calculate where an external force occurs. When using tactile sensors,sensors which are activated may directly show the location of theexternal force. For torque sensing at the joint, the algorithm may do anestimate to calculate where the input force may occur on the arm. Thealgorithm may read the type of input given, such as whether an input isa slow push, quick tap, a shake, or a pull.

In a step 4150, the first robotic arm may move, typically automatically,based on the determined user exerted force vector.

In a step 4160, the second robotic arm may move, typically automaticallyand concurrently, to maintain the virtual rail alignment with the firstrobotic arm. In some embodiments, a third robotic arm or further roboticarm(s) may move, typically automatically and concurrently, to maintainthe virtual rail alignment with the first and second robotic arms.

The first, second, and optionally further robotic arms may move in themany ways described below and herein, such as along one or more of anX-axis, a Y-axis, or a Z-axis (in which case the robotic arms may havethe same movement vectors) or to pivot or rotate about a point on thevirtual rail line (in which case the robotic arms may have differentmovement vectors and magnitudes). For example, a user such a physicianmay grab and move one of the end effectors and move the entire set ofend effectors which remain in the virtual rail alignment. In otherexamples, the robotic arms may be pivoted about a point where the sitewhere the endoscopic device or tool is introduced to the patient beingoperated on.

In some embodiments, the system may comprise a third or further roboticarm and the force exerted on a subset of the robotic arms (e.g., two ofthe robotic arms) may be detected so that entire set of the robotic armsare moved in a manner that maintains the virtual rail alignment. Forexample, a user such a physician may grab two of the end effectors andtranslate them with a substantially similar movement vector to each inone or more of the X-axis, Y-axis, or Z-axis and the remaining endeffectors may be automatically moved in a manner that maintains thevirtual rail alignment. In other examples, a user such as a physicianmay grab two of the end effectors and translate them with differentmovement vectors to each and the remaining end effectors may beautomatically moved in a manner that maintains the virtual railalignment and that rotates the end effectors about a point on thevirtual rail line. In still other examples, an end effector may begrabbed and rotated to rotate the virtual rail of end effectors aboutthe grabbed and rotated end effector. The movement of the robotic armsand the end effectors may be that of translation when the system detectsthat one of the end effectors is grabbed, for example, and the movementof the robotic arms and the end effectors may be that of rotation whenthe system detects that two or more of the end effectors are grabbed andtranslated, for example, or when a single end effector is rotated, asanother example.

In a step 4170, the admittance/impedance mode of the robotic surgerysystem may be disabled. The admittance/impedance mode may be disabled inany number of ways such as with voice control, joystick control, pedalcontrol, computer device control, sensor reading, time out, etc. Inother embodiments, the admittance/impedance mode may be disabled upondetecting the absence of external applied force. In some embodiments,either mode may be effectively disabled by a significant increase inforce threshold.

Although the above steps show the method 4100 of aligning the arms of arobotic surgery system in accordance with many embodiments, a person ofordinary skill in the art will recognize many variations based on theteaching described herein. The steps may be completed in a differentorder. Steps may be added or deleted. Some of the steps may comprisesub-steps. Many of the steps may be repeated as often as desired orbeneficial.

One or more of the steps of the method 4100 may be performed withcircuitry as described herein, for example, with one or more of aprocessor or logic circuitry such as a programmable array logic or fieldprogrammable gate array. The circuitry may be a component of the controlconsole or control computing unit described herein. The circuitry may beprogrammed to provide one or more of the steps of the method 4100, andthe program may comprise program instructions stored on a computerreadable memory or programmed steps of the logic circuitry such as theprogrammable array logic or field programmable gate array, for example.

Referring to FIG. 42A, a first robotic arm tool base 4208 and a secondrobotic arm tool base 4210 may be aligned to form a virtual rail 4209.As shown in FIG. 42A, the first and second robotic arm tool bases 4208,4210 may be translated concurrently in one or more of the X-axis X,Y-axis Y, or Z-axis Z while maintaining the virtual rail 4209.Typically, the axial distance between the first and second robotic armtool bases 4208, 4210 may remain constant through any movement. In suchmovements, the movement vector of the first and second robotic arms arethe same. In some cases, the axial distance may increase or decreaseduring the movement.

The first and second robotic arm tool bases 4208, 4210 may also be movedwith different movement vector to simulate the pivoting of the virtualrail 4209. As shown in FIG. 42B, the virtual rail 4209 may pivot aboutone of the tool bases such as the first robotic arm tool base 4208. Insuch cases, the movement vector of the second robotic arm tool base 4210may be substantially greater than the movement vector of the firstrobotic arm tool base 4210, which may be minimal. The first robotic armtool base 4208 may alternatively pivot about the second robotic arm toolbase 4210 as well.

As shown in FIG. 42C, the virtual rail 4209 may pivot about a pivotpoint 4213 on the virtual rail line between the first and second roboticarm tool bases 4208, 4210. In such cases, the movement vectors of thetwo robotic arm tool bases 4208, 4210 may be similar in magnitude butmay be opposite in direction.

As shown in FIG. 42D, the virtual rail 4209 may pivot about a pivotpoint 4215 on the virtual rail line beyond the first and second roboticarm tool bases 4208, 4210. In such cases, the movement vector of thesecond robotic tool base 4210 may be substantially greater than themovement vector of the first robotic arm tool base 4208. As shown inFIG. 42D, the pivot point 4215 lies on the virtual rail line to the“left” of the first robotic arm tool base 4208. Alternatively, the pivotpoint 4215 may lie on the virtual rail to the “right” of the secondrobotic arm tool base 4208.

While FIGS. 42B-42D show a pivoting of the virtual rail in thecounter-clockwise direction and with an angle of about 30 degrees, suchdirection and angle of pivoting is shown for example only. The virtualrail may be pivoted clockwise and with any angle between 0 and 360degrees as well.

Admittance/Impedance Mode.

In an operating room, where a doctor and an assistant are performing asurgical task, the assistant is typically holding an instrument for thedoctor. This instrument (such as a camera or retractor) often needs tobe periodically repositioned and thus cannot be held by a rigid fixture.The use of a robot could reduce the need for a human assistant, but thecontrol of many robots with a joystick or toggle buttons is notinstinctive. Likewise, setup of a robotic system for each new patient isslow, partially due to the inconvenience of the control interface to therobot. The present disclosure provides systems, devices, and methods inwhich sensors, gesture recognition, and admittance/impedance control areused to create a human-robot interaction mode which is instinctive andeasy.

The present disclosure provides for the sensing and control of the robotto take natural human inputs, such as a tap, push, or pull, on the armto command an expected motion. For example, a double tap on the “elbow”of the arm (e.g., a joint of the robotic arm) can mean the human wantsthe “wrist” to maintain position and to only move its elbow. In anotherexample, if the “forearm” (e.g., a link of the robotic arm) is heldfirmly and the “wrist” (e.g., the tool base, interface end, or devicemanipulator of the robotic arm) is pulled, it can mean the human wantsto arm to maintain position only rotate the “wrist.” In third example,if the “wrist” is pushed by itself, then it can mean the human wants towhole arm to follow the new position of the “wrist.” The robot does thisby sensing where and how the human is giving touch inputs to the arm,and uses that input (tap, double tap, tug, vibration, etc.) to enableadmittance mode, a control scheme in which the robot takes force inputas a motion command. The behavior of the admittance mode, such as whichjoints can be enabled or virtual limits on motion, is defined by thetype of human input given.

The use of natural human inputs may extend to instances outside ofmanipulating a virtual rail. In one embodiment, if an arm is in a pivotmode, a strong pull in an approximate direction may toggle admittancemode and retract the rail along a straight line through the pivot point.In another embodiment, if no tool is present on the end effector, alarge downward force applied by the physician may set the robot to astowage sequence to store the arms. In other embodiments, the system mayrequest confirmation prior to stowing the arms.

In some embodiments, admittance mode may be normally disabled. Thepresent disclosure provides precise control of the robot arm and cancompensates for external disturbances which may be unintended. When atouch gesture or input is given, the algorithm understands the user'sintent and enables an admittance mode to match that intended motion.This may replace other modes for toggling admittance mode. When theexternal force is removed, the algorithm senses no input and disablesadmittance mode, either instantaneously, after a given wait time, orgradually (by increasing virtual damping and stiffness).

FIG. 43 shows a flow chart illustrating a method 4300 for manipulatingthe robotic arm(s) of a robotic surgery system. The arms of the roboticsurgery system may be manipulated according to the method 4300 before,during, or after an operation on a patient.

In a step 4310, an admittance/impedance mode of the robotic surgerysystem may be enabled. The admittance/impedance mode may be enabled bythe user exerting a force (i.e., touching and contacting) the roboticarm as described above and herein. Alternatively or in combination, theadmittance/impedance mode may be enabled by user instruction receivedfrom a foot pedal in communication with the robotic arm, a joystick incommunication with the robotic arm, a voice command, a detected light,or a computing device in communication with the robotic arm, to name afew examples. In some embodiments, the initial position of the roboticarm may be memorized. In some embodiments, the robotic arm may beconfigured to be able to memorize a number of positions determined bythe user.

In a step 4320, the robotic arm may detect the force the user exerts onthe robotic arm, such as a touch, grab, a tap, a push, a pull, etc. Therobotic arm may comprise one or more links and joints; and, the roboticarm may comprise a torque sensor coupled to the joint or a tactilesensor coupled to the link, such as by being placed over the outersurface of the link. For example, the robotic arm may comprise a seriesof actuators held by links in-between and may comprise a 7 actuator,serial chain arm; and, the robotic arm may sense torque at each jointand/or have tactile sensing along the robotic arm. Alternatively or incombination, a force sensor may also be coupled to the tool base, devicemanipulator, or interface end of the robotic arm.

In some embodiments, tactile sensor and/or torque sensors may alsorecord the robot's physical interactions with the environment. Forexample, the sensors may capture inadvertent force from the physician(e.g., bumping) that may be analyzed to better determine and define theclinical and robotic workspace.

In a step 4330, the user intent may be determined based on the detectedforce. For example, the robotic surgery system may determine whether theexerted force is one or more of a hold, a push, a pull, a tap, aplurality of taps, a rotation, or a shake of at least a portion of therobotic arm. In some embodiments, the detected force may indicatetoggling admittance mode on or off.

The robotic arm may be coupled to a controller implementing an algorithmwhich can calculate where an external force occurs. When using tactilesensors, sensors which are activated may directly show the location ofthe external force. For torque sensing at the joint, the algorithm maydo an estimate to calculate where the input force may occur on the arm.The algorithm may read the type of input given, such as whether an inputis a slow push, quick tap, a shake, or a pull. The algorithm can use alibrary of cases to toggle between different admittance modes. Thislibrary can be preset or adaptively learned. In some embodiments, therobotic arm may be response to voice or other commands in addition to orinstead of touch commands.

In a step 4340, the robotic arm may be moved based on the determineduser intent. In some embodiments, the admittance/impedance mode may beenabled based on the detected force, i.e., if the exerted force matchesa pattern for enabling the admittance/impedance mode. The robotic armmay also move in a variety of patterns based on the characteristics ofthe force exerted on it. For example, it may be determined that theforce exerted on the robotic arm comprises at least one tap on a jointof the robotic arm, and the joint of the robotic arm may beautomatically moved while maintaining a position of at least one otherjoint or interface end of the arm. In another example, it may bedetermined that the force exerted on the robotic arm comprises a pull onan interface end of the robotic arm while a position of a joint of therobotic arm is maintained, and the interface end of the robotic arm maybe simply rotated. In yet another example, it may be determined that theforce exerted on the robotic arm comprises a push or pull on aninterface end of the robotic arm, and the interface end of the roboticarm may be automatically moved in response to the push or pull on theinterface end and the whole robotic arm may be automatically moved tofollow the movement of the interface end.

In some embodiments, the behavior of another part of the robotic surgerysystem may change in response to the user exerted force or touch. Forexample, a double tap on the base of the robot may enable a pump. In oneembodiment, a large or sudden force may set the robot into a “safe”state where no commands may be triggered by external force or touch. Inanother embodiment, a “master/slave” or “mirroring” mode may make use offorce and torque readings from arms on one side of a surgical bed tocommand motions on arms on the other side of the bed.

In a step 4350, the admittance/impedance mode of the robotic surgerysystem may be disabled. In some embodiments, the robotic arm may returnto the initial position it had memorized. In some embodiments, therobotic arm may be instructed to return to any of the preset positionspreviously memorized. The robotic arm may be instructed through any ofthe control schemes described herein. In some embodiments,admittance/impedance mode of the robotic surgery system may not bedisabled after movement until operator command to do so.

Although the above steps show the method 4300 of manipulating therobotic arm(s) of a robotic surgery system in accordance with manyembodiments, a person of ordinary skill in the art will recognize manyvariations based on the teaching described herein. The steps may becompleted in a different order. Steps may be added or deleted. Some ofthe steps may comprise sub-steps. Many of the steps may be repeated asoften as desired or beneficial.

One or more of the steps of the method 4300 may be performed withcircuitry as described herein, for example, with one or more of aprocessor or logic circuitry such as a programmable array logic or fieldprogrammable gate array. The circuitry may be a component of the controlconsole or control computing unit described herein. The circuitry may beprogrammed to provide one or more of the steps of the method 4300, andthe program may comprise program instructions stored on a computerreadable memory or programmed steps of the logic circuitry such as theprogrammable array logic or field programmable gate array, for example.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

Elements or components shown with any embodiment herein are exemplaryfor the specific embodiment and may be used on or in combination withother embodiments disclosed herein. While the invention is susceptibleto various modifications and alternative forms, specific examplesthereof have been shown in the drawings and are herein described indetail. The invention is not limited, however, to the particular formsor methods disclosed, but to the contrary, covers all modifications,equivalents and alternatives thereof.

What is claimed is:
 1. A system of robotic arms comprising: a firstrobotic arm coupled to and configured to position a first tool base of afirst tool, the first robotic arm comprising a force sensor configuredto detect a force exerted on the first robotic arm; a second robotic armcoupled to and configured to position a second tool base of a secondtool such that the first and second tool bases are positioned at apredetermined separation distance and orientation relative to oneanother to form a virtual rail that facilitates insertion of the firsttool and the second tool; and a controller coupled to the first andsecond robotic arms, the controller configured to: move the first toolbase with the first robotic arm with a first movement vector in responseto the detected force exerted on the first robotic arm; and move thesecond tool base with the second robotic arm with a second movementvector in response to the detected force exerted on the first roboticarm such that the predetermined separation distance and orientationbetween the first and second tool bases is maintained; wherein thesystem of robotic arms further comprises a third robotic arm configuredto position a third tool base, the first, second, and third tool basesbeing at predetermined separation distances and orientations relative toone another.
 2. The system of claim 1, wherein the predeterminedseparation distance and orientation between the first and second toolbases forms a virtual rail therebetween.
 3. The system of claim 1,wherein the predetermined separation distance and orientation betweenthe first and second tool bases comprises a linear alignment between thefirst and second tool bases.
 4. The system of claim 3, wherein thelinear alignment comprises a linear alignment between an interface endof the first robotic arm and an interface end of the second robotic arm.5. The system of claim 1, wherein the controller is configured to pivotthe first and second tool bases about a point on a line extendingthrough the first and second tool bases.
 6. The system of claim 5,wherein the point on the line is between the first and second toolbases.
 7. The system of claim 5, wherein the point on the line is beyondthe first and second tool bases.
 8. The system of claim 1, wherein thecontroller is configured to translate the first and second tool bases inunison.
 9. The system of claim 1, wherein the first movement vector andthe second movement vector are the same.
 10. The system of claim 1,wherein the first movement vector and the second movement vector aredifferent.
 11. The system of claim 1, wherein the controller isconfigured to automatically move the third robotic arm with a thirdmovement vector in response to the detected force such that thepredetermined separation distance and orientation between the first,second, and third tool bases is maintained.
 12. The system of claim 1,wherein the predetermined separation distance and orientation betweenthe first, second, and third robotic arms comprises a linear alignmentbetween the first, second, and third tool bases.
 13. The system of claim1, wherein the first robotic arm comprises at least one joint and atleast one link, and wherein the force sensor of the first robotic armcomprises a torque sensor coupled to the at least one joint.
 14. Thesystem of claim 1, wherein the first robotic arm comprises at least onejoint and at least one link, and wherein the force sensor of the firstrobotic arm comprises a tactile sensor coupled to the at least one link.15. The system of claim 1, wherein the controller is configured toenable a movement mode of the system of robotic arms in response to thedetected force.
 16. A system of robotic arms comprising: a first roboticarm coupled to and configured to position a first tool base of a firsttool; a second robotic arm coupled to and configured to position asecond tool base of a second tool such that the first and second toolbases are positioned at a predetermined separation distance andorientation relative to one another to form a virtual rail thatfacilitates insertion of the first tool and the second tool; a thirdrobotic arm coupled to and configured to position a third tool base in amanner such that the first, second, and third tool bases are positionedat predetermined separation distances and orientations relative to oneanother; and a controller coupled to the first and second robotic arms,the controller configured to: (i) automatically move the first tool basewith the first robotic arm with a first movement vector in response to adetected force on the first robotic arm; and (ii) automatically move thesecond tool base with the second robotic arm with a second movementvector in response to the detected force such that the predeterminedorientation between the first and second tool bases is maintained. 17.The system of claim 16, wherein the controller is further configured todetermine a user input to cause the system to enter an admittance modeprior to automatically moving the first and second tool bases.
 18. Thesystem of claim 17, wherein the controller is further configured todetermine the user input by determining that a button or switch has beenactivated.
 19. The system of claim 17, wherein the controller is furtherconfigured to, when in the admittance mode: receive a force feedbacksignal based on the detected force; determine the first movement vectorbased on the force feedback signal; provide to the first robotic arm, afirst command to move the first tool base along the first movementvector; and provide to the second robotic arm, a second command to movethe second tool base simultaneously with the first tool base along thesecond movement vector to maintain the predetermined distance andorientation between the first and second tool bases.